Director, QA Resume Sample
Lauretta Stoltenberg
3278 Harvey Crossroad,
Phoenix,
AZ
+1 (555) 866 9670
Work Experience
Director, QA
08/2016
-
PRESENT
San Francisco, CA
- Maintains professional and technical knowledge by attending educational workshops’ reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; and participating in professional societies
- Experience in a GMP regulated environment, with exhibited knowledge or proficiency at qualification, validation and change control
- Organizational and management skills to coordinate multi-discipline project groups, with ability to effectively delegate work
- Comprehend technical information related to facilities, equipment, computerized systems, and regulatory expectations
- Experience in: project scope development, Request for Proposal development, contractor selection and contractor management
- Experience in large and small project implementation and budgeting
- Experience with large scale test automation frameworks
- Excellent multi-tasking, analytical and decision-making skills with the ability to troubleshoot identify root cause and systematically solve problems
- Very detail oriented and analytical person, who measures metrics for quality, performance, and benchmarks against previous software releases
Director QA
09/2013
-
06/2016
Los Angeles, CA
- Strong English communication skills, both oral and written with the ability to facilitate meetings, conduct trainings and to present information in an advisory capacity
- Travel as required by the position
- Full understanding of the company’s products, services, mission, goals and strategic business plan
- Committed to working with shared leadership and in cross-functional teams
- Adapts to change in business trends
- Drive the organization’s efforts for improving our automated tests and reduce time to market for our SaaS offering
- Experience of web, mobile web, native mobile, connected TV. Experience with .NET infrastructures and cloud hosting desirable
- Track record of defining test and release processes that allow for continuous delivery
Associate Director / Director, QA Validation
10/2006
-
03/2013
Boston, MA
- Demonstrated experience liaising with executives, product managers and other non-technical functions with the ability to present complex technical information in a clear and concise manner to a variety of audiences
- Experienced in test automation desirable
- Develop a product testing strategy covering long term and short term recommendations and actions
- Evaluate and interpret US and Global regulations, guidance’s, standards to ensure that the site and product complies with all applicable regulations and submissions
- Serve as Teva’s Quality Assurance leader in work with Contract Research Organizations (CRO) and Contract Manufacturing Organizations on product implementation and technology transfer, Quality Agreements, Audits, and support for inspections
- Serve where required as Teva’s Primary Quality Assurance representative in regulatory agency inspections and partner/Teva Audits, and coordinate inspection response strategy
- Recommends and approves courses of action on all management / human resources’ matters
Education
University of Wisconsin-Richland
2001 - 2006
Engineer's Degree in Engineering
Professional Skills
- Excellent oral and written communications skills and experience interacting with both business and engineering individuals at all levels
- Proven, measurable leadership skills
- Excellent cross-group collaboration skills with the ability to work across functional areas and geographies
- Demonstrated experience leading and successfully delivering on high-profile quality initiatives with senior executive leadership visibility
- Effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company
- Generation, reviews and approval of the Validation Master Plan and Validation Protocols, executed protocols, and summary reports at both Akebia and CMOs
- Demonstrable leadership and communication skills
How to write Director, QA Resume
Director, QA role is responsible for leadership, engineering, communications, shipping, training, integration, recruiting, auditing, security, planning.
To write great resume for director, qa job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director, QA Resume
The section contact information is important in your director, qa resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Director, QA Resume
The section work experience is an essential part of your director, qa resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, qa responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, qa position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director, QA resume experience can include:
- Defines departmental roles and accountabilities and, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives
- Manage, review and approve validated system Change Controls and assessments for Cleaning and Steaming Validation
- Assuring the viability, functionality and effectiveness of essential tools
- Quality oversight for the execution of Automation qualification and validation commissioning and qualification
- Quality oversight for the execution of Cleaning and Process validation
- Quality oversight of Intarcia’s validated systems
Education on a Director, QA Resume
Make sure to make education a priority on your director, qa resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, qa experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Director, QA Resume
When listing skills on your director, qa resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical director, qa skills:
- Communicating and collaborating effectively regarding issues, objectives, initiatives and performance to plan
- Communicate effectively and function cooperatively with other staff, management and auditors. Ability to supervise and schedule staff
- BS with 10+ years relevant QA experience and at least 10+ of relevant and supervisory experience
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- Owning the Validation program and strategy
- Proven background in building Quality Assurance Teams
List of Typical Experience For a Director, QA Resume
1
Experience For Director QA Resume
- Review and approval of FUE as well as Cleaning and Steaming protocols, reports and Validation Discrepancy Reports (VDRs)
- Direct initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures
- Experience in a similar leadership role
- Manage, review and approve validated system Change Control and assessments for FUE and Automation projects
- Understanding of project management methodology; tolerances, change, and gates
- Is the primary contact with regulatory health authority agencies and liaison during regulatory inspections
- Serve as Global QA Contact for assigned customers and Quintiles functional areas
- Ensure that all products manufactured at the site are produced, tested, and released in compliance with SOPs, cGMPs and global regulations. Ensures systems, resources, and action plans are reviewed and decisions made to attain sustainable compliance
- Make decisions regarding quality control and compliance for all batches and products, including discrepant batches (investigations, retesting and re-inspections.) Manages the review of complaint investigations. Makes full batch rejection and recall decision in conjunction with Executive Director, Quality Ops
2
Experience For Director, QA Technical Testing Resume
- Oversee the establishment of all systems, procedures and specifications affecting product quality (e.g., batch records, SOPs, validation protocols and reports) to minimize errors and eliminate the possibility of non-compliant products being produced or released
- Responsible for maintaining quality KPI’s/metrics and data for the periodic quality management review
- Represent the site for establishment of Company-wide quality policies, strategies and practices
- Establish and manage the Quality Operations budget
- Verify that necessary actions have been properly taken to ensure continuous improvement
- Give instructions, where necessary, to take improvement actions in cases where defects or potential risks could affect the quality of products
- Participate in review and closure of corrective actions, as required
- Act as a resource for information, consultation and training concerning applicable regulations, guidelines and quality issues to study teams, working groups, and task forces for assigned projects
3
Experience For Associate Director / Director, QA Validation Resume
- Ensure highly disciplined compliance with all regulatory and SunOpta defined food safety and sanitation standards, systems, procedures and practices to guarantee wholesomeness of product
- Provide guidance and direction to plant teams ensuring compliance with SunOpta’s food safety and quality policies and procedures
- Manage the plant quality assurance team activities including travel, plant audits, setting objectives, priorities, and issue management protocols and procedures
- Provide resources for plant trials and utilize data to participate in the development of product specifications with R&D and the plant Quality team
- Provide support for Procurement, Operations, Marketing and Sales regarding quality inquiries and complaints. Analyzes trends in complaints and develops action plans. Assures appropriate records and samples are retained on any issues investigated upon closure
- Leads plant quality teams in the development, execution and tracking of partner corrective action plans that drive improved compliance, continuous improvement, and increased performance efficiencies
- Ensures that program and system implementation internally, and externally allows for solid traceability of all products produced and shipped
- Develop KPIs, set improvement targets, track and report performance with the plant leadership team, division leaders and corporate team
- Approve new customer/product review and complete associated set-up documents (on-site launches as necessary)
4
Experience For Senior Director, QA Resume
- Stay current with all key regulatory and certifying agency guidelines. Ensure factories maintain all certifications needed to manage customer needs, e.g. SQF, Kosher, Halal, QAI or other
- Establish performance objectives and criteria for plant Quality Assurance Managers. Drives quality and process improvement initiatives through the continuous improvement program
- Provides goal setting direction, training and development for site Quality Managers and assists in the development of the quality team at these sites
- Quality oversight for the execution of Facility, Utility and Equipment system
- Quality assessment and approval of process and systems changes
- Quality oversight of NPI process for FMC
- Direct QA resources in support of projects
5
Experience For Director, QA Operations Resume
- Work closely with product managers on the implementation of new products and infrastructures including operational readiness, change preparation, change execution, and post-change QA validation
- Coordinate with product management on roadmaps, automation, and operational improvement activities across the environment with accountability for continuously raising the bar on operating level agreement targets
- Recruit and maintain a strong team capable of addressing test plans
- Deep working experience in Agile development process
- Embodies the QA strategy, instilling shared values and focus areas within the function. Guide and inspire the studio QA teams, acting as a translator of high level, long-term vision and strategy into concrete direction and action plans for the team, highlighting relevance and benefits to studio level
- Creates productive working relationships with other discipline leaders within the company to increase goal alignment and represent the value of Quality Operations to studio leadership
- Identifies and implements process improvements: evolves, optimizes, and defines company-wide processes that can benefit multiple projects in a proactive manner
- Design test strategies using a variety of techniques, tools, and technologies: selects the appropriate methods based on defined objectives including cost, efficiency, effectiveness, and balancing available resources, uses information and business systems to support planning and tracking of activities
6
Experience For Associate Director, QA Site Compliance Resume
- Liaises on external issues requiring attention, helps set priorities and directs partner teams like Publishing, Marketing, and Central Operations in relation to QA best practice
- Contributes with industry experience, quality discipline and management knowledge and insight into capabilities – people, technology, and QA partners
- Provides options and makes decisions about the balance between quality, time, and cost
- Pushes for efficiencies and sets quality goals, drives the quality goal to completion
- Familiarity with the software project lifecycle related to games as a service
- Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
- Participate in investigations associated with product
- Lead and coordinate Quality Assurance teams that consist of manual and automation testers
7
Experience For Executive Director, QA / RA PMO Resume
- Responsible for defining and maintaining written procedures for executing each standard test plan and ensuring adherence to these procedures by all QA team members
- Responsible for developing and maintaining software utilities, scripts, test plans, test cases and test tools used to facilitate execution of standard test plans for HealthPort products
- Represent QA team at internal development, status and project review meetings
- Oversee initiatives to maintain and enhance quality compliance in adherence to HealthPort development methodology
- Define and manage product specific QA teams (Health Information Technology, Release of Information) to develop, execute and maintain the test framework and test scripts to support unit, functional, regression, performance, integration and system level testing
- Collaborate and foster a positive environment with Product and Program Managers, development, test and documentation team members in all phases of application development at HealthPort
8
Experience For Senior Director QA Resume
- Utilizes superior change management skills to propose and implement key process improvement and adoption of best practices across all phases of quality assurance activities
- Fosters positive relationships with clients while providing oversight of test requirement gathering, development, review and signoff of test plans & conditions
- Implement test automation framework for all software products developed by HealthPort and custom Lawson programs
- Provide strategic leadership and recommendations to HealthPort executive team to improve and maintain overall software quality
- Plan, organize, and manage the functions of the Validation Department, with respect to facility, utility, equipment (FUE), manufacturing analytical instrumentation, and automation qualification
- Partner with Global Validation to deliver process validation and CSV projects
- Execute (protocol generation, execution, discrepancy generation/resolution support, system review and final package preparation) for the Cleaning and Steaming Revalidation Evaluation (RVE) Program
9
Experience For Director, QA Oversight Resume
- Provide oversight for FUE/Automation Qualification projects
- Coordination and management of Cleaning and Steaming Validation projects related to the implementation of new manufacturing systems and changes to existing systems
- Review and approval of FATs. SATs, ATs, CTPs
- Review and approval of User Requirement Specifications (URS’s) and Functional Requirement Specifications (FRS’s)
- Review and approval of Design Review documentation, engineering drawings, Personnel Flow drawings, Process Flow drawings, HVAC balance documentation and alarm requirement specifications
10
Experience For Director, QA GMP Resume
- Quality and Validation representative on project teams
- Owner of the System Area Release (SAR) SOP as well as post approval of all SARs
- Owner of the SOP-104127, "Novato Implementation of the Global Calibration Program."
- Review and approve Instrument Request Form/Instrument Criticality (ERF) documents
- Assist in the development, analysis, and management of the annual budget for internal and external resources and expenses for FUE/Automation Qualification as well as Cleaning and Steaming Validation
- Participate in inspection preparation, train employees in inspection requirements and participate in regulatory inspections, defending validation functions and studies for FUE/Automation as well as Cleaning/Steaming
- Support CMC regulatory filings for all drug products
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and validation approaches and systems utilized at BioMarin
- Development and implementation of SOPs/Guideline documents with systemic procedural improvements for FUE/Automation Qualification as well as Cleaning and Steaming Validation
List of Typical Skills For a Director, QA Resume
1
Skills For Director QA Resume
- Experience leading multi-function teams with at least 25 - 50 team members including Automation, and Quality Assurance Engineers
- Good understanding of and ability to interpret cGMP, licensing and certification requirements
- Good understanding of product development and testing processes, tools, metrices etc.,
- Solid understanding of software development life cycle as well as expertise in quality assurance processes and methodologies
- Experienced in industry best practices of quality engineering and software development
- Handle multiple assignments and changing priorities
- Managing planning and execution of product testing efforts, including all associated resources to meet committed delivery dates
- Understanding of packaging & labeling operations
- Ensuring delivery against QA department goals and objectives, i.e. Meeting commitments and coordinating overall quality assurance schedule
2
Skills For Director, QA Technical Testing Resume
- Mentoring the team through frequent one on ones, quarterly goals setting and tracking, annual performance reviews and other relevant managerial tasks
- Understanding of utilization of automation in software testing
- Providing necessary definition, development and deployment of product quality assurance strategy, addressing all phases of product development
- Working closely with development manager(s) and other peer managers in the product cycle to make necessary quality impact
- Preparing comprehensive QA plans, defect metrics and QA reports as required by the project
- Reviewing development specifications to understand QA scope & impact
3
Skills For Associate Director / Director, QA Validation Resume
- Performs activities in support of dispositioning packaging & labeling product while ensuring compliance with policies and procedures, cGMPs, etc
- Responsible for choosing the best in class tools for testing, documentation and releasing high quality software
- Responsible for staff hiring, goals and objectives, performance reviews, development, training, and mentoring
- Manage career paths and grow the QA team across multiple applications, meeting engineering goals
- Passionate for testing and Quality and being more focussed towards test automation to increase efficiency and productivity
- Assist with the build and support of automated testing frameworks including continuous integration and deployment platforms
4
Skills For Senior Director, QA Resume
- Responsible for setting the testing strategy and plan for the company
- Responsible for owning the quality assurance processes and deliverables, and recommending future state processes and solutions
- Responsible for generation of the Annual Product Review (biologics) for FUE/Automation activities as well as Cleaning and Steaming
- Establishes rework standards by devising inspection and physical testing methods and procedures
- Be responsible for identifying risks and working with the appropriate product development owners to
- Responsible and accountable of flagging the timing of interdepartmental deliverable and the quality of their output
- Lead a team of QA Managers and QA engineers, delivering quality applications
- Maintains Audit Files and Tracking Log
- Establishes contract agreements and Statement of Works (SOWs) with the contract auditors according to the internal process with Halozyme Legal input
5
Skills For Director, QA Operations Resume
- Assists in the conduct of regulatory training for GCP/GLP/GvP as needed
- Define/manage plans to improve product quality, organization and implement those plans to be proactive in continually improving the test process
- Review and approval of maintenance documentation: PM extensions, Steam Quality Testing and Stainless Steel Inspections
- Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures
- Promote open communication (Exceptional communicator who is able to work with all levels of the organization)
- Interacts with other employees, and as required, with external representatives from across the supply chain for product
- Plan, organize, and direct the QA CSV group
6
Skills For Associate Director, QA Site Compliance Resume
- Take the initiative to create and implement a plan to enhance, optimize and improve QA CSV systems at the global level by generating applicable policies, processes and governance
- Establish effective communication and collaborative relationships with other functional groups and key stakeholders
- Own and provide guidance for Technical Operations about how to conduct data
- Integrity assessments and establish and then manage data life cycles
- Establish operational objectives and metrics
- Represent QA CSV and participate in multi-departmental meetings
- Develop, define, and enforce global and departmental policies and practices for functional groups
- Maintains working knowledge of FDA, EU and other global regulations and guidance governing Good Clinical Practice (GCP), Pharmacovigilance (PV) and Good Laboratory Practice (GLP) activities
7
Skills For Executive Director, QA / RA PMO Resume
- Ensures the quality & compliance of Halozyme’s clinical development & clinical operations activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
- Prepares and conducts or assists contract auditors for GxP audits per established strategies
- Conducts QA review of draft protocols; Informed Consent Forms, aggregate safety reports, and other clinical trial specific documents, when requested
- Conducts QA review of Clinical Study Reports and communicates findings to the appropriate team
- Conducts risk-based audits of service providers, internal systems and clinical investigators involved with Halozyme clinical trial programs
- Assists in the review of clinical trial related SOPs
- Ensures standardization and compliance with established standards, policies and procedures of Conifer Revenue Cycle Solutions, regulations of applicable regulatory agencies in Outsourcing Operations. Establish monitoring systems for Outsourcing functions. Recommends standard policies and procedures for providing routine service. 10%
- Collaborates with all segments of leadership responsible for process design and development, process monitoring, and policy and procedure development. Manages all aspects of change management as it relates to operational processes, driving process metrics, staffing and employee relations, etc.15%
8
Skills For Senior Director QA Resume
- Strong communicator/verbal and written
- Coaching, as the site expert, on the regulatory and compliance requirements in regards to GMP’s within the labs (GLP’s)
- In Audit, Compliance, Quality or Manufacturing Operations and 5 years leading people
- In-depth knowledge of commercial software testing suites
- Think strategically while still managing operational work
- In-depth knowledge of commercial continuous integration
- Quality oversight of contract manufacturing operations for clinical trial materials. Includes review and approval of change control requests to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicable
- Oversee and monitor Quality Assurance processes with focus on master production and control records to ensure that production and control operations are adequately defined and that good manufacturing practices are utilized for the manufacture of drug substances and drug products at CMOs
9
Skills For Director, QA Oversight Resume
- Experience in IT project management (multiple fields) or related field (including process improvement)
- Manage review of product release and stability data, support method transfers and validations
- Management and leadership experience, leading both technical and QA orgs
- Solid understanding of appropriate tools
- Proven ability to release web-based software products with quality and ensure objectives, goals, and commitments are met
- Significant experience in review of quality system, complex decision making and drug substance and raw material disposition requirements
10
Skills For Director, QA GMP Resume
- Extensive experience with implementing phase appropriate controls (early stage clinical versus commercial)
- Demonstrated ability to work in a multi-disciplinary setting acting as facilitator
- Demonstrated complex problem-solving ability
- Excellent manager: able to build and manage a world class team to deliver world class product
- Responsible for material disposition of clinical trial materials to support clinical operations includes certificate of analysis generation
- Performs technical assessments and QA approval of deviation and OOS investigations for clinical products
- Participate and/or Conduct Risk Assessment and / or Failure Mode and Effects Analysis activities for both Design and Process FMEA's
- Participate in Material Review Board- recommend disposition and corrective action
List of Typical Responsibilities For a Director, QA Resume
1
Responsibilities For Director QA Resume
- Generation of project validation master plans, core validation master plans and additional supporting documentation for FUE/Automation Qualification as well as Cleaning and Steaming Validation
- Product development or quality engineering experience
- Experience leading a team of QA engineers through a product cycle
- Represent Validation in multi-departmental meetings & project teams
- Strive toward constant improvement of validation systems in order to maintain compliance cGMP requirements for work performed
- Skilled in applying knowledge and techniques to solve problems
- Experience with: VSS/CVS, Toad, Lawson, SQL
2
Responsibilities For Director, QA Technical Testing Resume
- Experience with automation test tools and techniques (Perl, PHP, Bash, Python)
- Hire, train, evaluate, discipline, and support supervisors and employees in group
- Assist in development, implementation, and enforcement of departmental policies and practices
- Member of the Novato Site Quality Leadership Team
- Provide guidance, interpretation, support, training, and key input to clinical development operational staff on interpretation of applicable regulations, guidelines, corporate standards, and policies
3
Responsibilities For Associate Director / Director, QA Validation Resume
- Plan,schedule,conduct, report and close audits of laboratory activities
- Serve as QA Contact for assigned customers and functional areas
- Track, trend, and report Quality Metrics for the site
- Conduct trend analysis of audit findings and Quality Issues and provide QA management with initial root cause analysis
- Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers
4
Responsibilities For Senior Director, QA Resume
- Establishes raw material standards by studying manufacturing and engineering requirements; conferring and negotiating with suppliers; devising testing methods and procedures
- Maintains product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with other members of management to develop new product and engineering designs and manufacturing and training methods
- Ensure critical and high-risk items are prevented prior to release
- Own QA of multiple applications being built from Toronto office
- Own QA of other tools (API, renditions) that help support our Vault platform
- (General Release) on time and with quality
- Drive multi-team interaction and collaboration to meet product release readiness
- Working with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation
5
Responsibilities For Director, QA Operations Resume
- Anticipating program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments
- Directly supervise quality assurance managers, team lead(s), QA/testers including the preparation and delivery of staff performance evaluations and career development activities
- Collaborates with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities
- Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement
- Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
- Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams
- Supports the management and resolution of significant issues relating to quality
- In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage
- Contributes to the development of the global risk-based internal audit plan
6
Responsibilities For Associate Director, QA Site Compliance Resume
- Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites
- Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts
- Interfaces with senior management to discuss quality and compliance issues
- Interfaces with business development and operations to identify business opportunities
- Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented
- Experience in pharmaceuticals or biologics industry with at least 5 years in Quality Assurance and increasing management responsibility
- Proven track record in personnel management of a bigger team
- Experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
- Platform testing experience; Mac, NT, Unix, Windows 2000, Windows 98 and Windows XP
7
Responsibilities For Executive Director, QA / RA PMO Resume
- Knows at least two programming languages (i.e., VBScript, C#, Java)
- Automated testing tools; HP Mercury Test suite
- Education: BS in CS or EE
- Good knowledge and background experience with any of : Electronics component, Printed Circuit Board (PCB), Mechanical, Metal Stamping, Plastic moulding manufacturing process
- Enough level of technical background to provide highly-credible leadership to QA teams and to be able to accurately and objectively evaluate complex project risks and issues
- Innovate and contribute to the evolution of Quality Assurance best practices while successfully releasing quality applications to customers
- Develop trusted relationships with cross-functional stakeholders to drive quality releases
- Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance
- Practical experience applying proactive quality approaches for clinical trials
8
Responsibilities For Senior Director QA Resume
- Strong negotiation and influencing skills; demonstrated ability to work constructively and effectively at all levels across functions as well as with external customers
- Superb and polished ability to consistently present information in a clear, compelling, and understandable format, tailoring presentations to the context and audience
- Demonstrable experience and ability to utilize analytics to make data-driven decisions and assess impact of interventions
- Willing to travel globally, including outside normal working hours (approx. 30%)
- Deliver business value across distributed service delivery teams using Continuous Integration, Continuous Delivery within a DevOps arena
- Lead and direct the team to ensure all solutions and systems are delivered with high quality and testing platforms meet the needs of end users while adhering to West’s corporate policies, procedures and philosophies
- Ensure quality in platform and product deliverables
9
Responsibilities For Director, QA Oversight Resume
- Partner strategically with internal and external clients to shape roadmaps
- To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures
- One program platform is required (RHEL, AIX, Windows)
- Recognize the need for and effect improvements
- Knowledge of current regulations governing Development of Biologics and Pharmaceutical GMPS and the ability to apply to the relevant development, manufacturing, and quality control areas
10
Responsibilities For Director, QA GMP Resume
- Very strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments
- Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 5 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
- Experience in setting up and managing cGMP quality systems, including validation, Material disposition, Certificates of Analysis, Stability monitoring and Specifications. Expert knowledge of FDA, EU, ICH, ISO requirements for GXP areas
- Lead and work with others, including CMOs
- Knowledge of FDA, EMA GMP requirements
- Results-oriented: tenacious, gets things done
- Relevant post-graduate qualification in technology or financial markets would be helpful
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