Associate Director, Quality Assurance Resume Sample
Mathilde Stanton
3215 Ondricka Parkways,
Dallas,
TX
+1 (555) 721 6413
Work Experience
Associate Director, Quality Assurance
09/2017
-
PRESENT
Detroit, MI
- Provide input to, assist with the integration of, and verify execution of the process quality strategy to ensure the implementation, training, execution and control of robust MRL processes which meet applicable regulatory requirements. Ensure that MRL functional areas understand the strategy and implement the necessary processes and controls to achieve the strategy
- Provide input to, assist in the integration of and verify execution of a vendor quality strategy to ensure that MRL vendors meet MRL standards and regulatory requirements. Ensure that MRL functional areas understand the strategy and implement the necessary processes and controls to achieve the strategy
- Under the guidance of the vendor quality lead, work with vendors and MRL functional areas to ensure implementation of quality plans, KPI’s and KQI’s, where appropriate. Assist with the integration of quality considerations into the vendor selection process
- Provides input on, assists with the integration of, verifies execution of the technology strategy to help ensure that MRL systems, software and instruments meet MRL and regulatory requirements. Help ensure that MRL functional areas understand the strategy and facilitate the implementation of the necessary processes and controls to achieve the strategy
- Provide support for regulatory authority inspections including conducting pre-inspection audits of sites, CRO’s and processes
- Develop strategy and lead implementation of the CAPA management process across the contract/external laboratory network; define the strategy for global requirements to drive harmonization of processes and systems related to contract/external laboratory management
- Lead the implementation of QMS requirements related to CAPA Management and Compliance Remediation Support at contract/external laboratories
- Ensure quality requirements are sound and compliant by using insights, experience and judgment to proactively drive and improve the company’s QMS processes and alignment related to GMP and Data Integrity requirements for contract/external laboratories
Associate Director, Quality Assurance GMP
02/2012
-
03/2017
Philadelphia, PA
- Provide leadership and technical direction on regulatory GMP requirements to contract/external laboratories
- Initiate, where appropriate, and lead communities of practice to drive best practice sharing and continuous improvements across the MMD network
- Develop and proactively identify, investigate and resolve trends and patterns before they impact compliance and supply; define and drive implementation of performance metrics, as appropriate, to measure performance across the contract/external laboratory network
- Influence and advocate Merck’s position on CRS processes related to HA expectations through a strong network of external connections and effective external engagement
- Anticipate external trends through benchmarking and regulatory intelligence activities and prepare the company proactively for changes and continuous improvements
- Lead, Act, and Support activities to ensure robust processes are in place and in use to maintain the Merck CRS and associated documents
- Identify and implement areas for improvement in the constantly evolving QA processes with the SDLC
Associate Director, Quality Assurance GCP
01/2009
-
01/2012
Detroit, MI
- Hands-on experience in C++ and .NET, scripting languages, and SQL databases
- Lead and mentor direct reports for proper representation at CMC teams. Align strategy and messaging
- Identify areas for improvement and lead change for implementation
- Enable Effective Formation of Clinical QA sub-teams across QA internal functions
- Provide expert quality and compliance advice and support to ensure cGMP compliance
- Provide single point of contact and representation for QA department for CMC
- Provides support for all regulatory inspections, at Ironwood and it’s CMOs
- Review CMC sections of regulatory submissions for IND’s, CTA’s, NDA’s, etc. as assigned
Education
Wittenberg University
2004 - 2009
Bachelor's Degree in Chemistry
Professional Skills
- Strong collaborative, partnering, and interpersonal skills
- Excellent analytical, written and oral communications skills (English)
- Demonstrated analytical, problem-solving, and communication (oral/written) skills
- Supervisory experience, leadership, and teamwork skills
- Proven experience in Test Management and an understanding of System, Integration, and Functional testing execution
- Prior experience in interfacing and leading regulatory audits
- A strong laboratory background with understanding of the use and validation of laboratory systems from the end-users perspective
How to write Associate Director, Quality Assurance Resume
Associate Director, Quality Assurance role is responsible for software, training, integration, database, auditing, manufacturing, design, research, travel, events.
To write great resume for associate director, quality assurance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate Director, Quality Assurance Resume
The section contact information is important in your associate director, quality assurance 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 Associate Director, Quality Assurance Resume
The section work experience is an essential part of your associate director, quality assurance 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 associate director, quality assurance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate director, quality assurance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate Director, Quality Assurance resume experience can include:
- Strongly developed cross-functional teamwork, collaboration, influencing and negotiating skills
- Good interpersonal/communication/influencing/negotiation skills required
- Demonstrated operational management experience, including capacity planning and scheduling
- Use judgment, clear problem-solving and decision-making skills
- Exceptional client facing and presentation skills
- Effectively presents information in a group setting
Education on an Associate Director, Quality Assurance Resume
Make sure to make education a priority on your associate director, quality assurance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate director, quality assurance 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 Associate Director, Quality Assurance Resume
When listing skills on your associate director, quality assurance 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 associate director, quality assurance skills:
- Teamwork- Strong interpersonal skills with the ability to work effectively in teams
- Effective communication skills (verbal, written, interpersonal, organizational), capable of setting priorities
- Flexible with the ability to effectively manage multiple competing priorities
- Solid problem-solving, troubleshooting and organizational skills
- Possesses strong organizational, planning, project management and communication skills
- Decision Making- Demonstrates good judgment and decision making
List of Typical Experience For an Associate Director, Quality Assurance Resume
1
Experience For Associate Director, Quality Assurance GMP Resume
- Strong foundation in core Business Analyst and Quality Assurance skill sets
- Demonstrated strong customer focus ability with internal and external customers
- Experience in setting up and running QA Automation
- Previous experience presenting and responding to regulatory agency audits
- Strong working knowledge of cGMP global regulations (21CFR210, 211, 820, 4), ISO 13485, CE Marking and ICH guidance’s
- Deep knowledge and experience managing QA with multiple SDLCs such as Agile, Scrum and traditional waterfall
2
Experience For Associate Director, Quality Assurance, CMO Resume
- Experience managing QA Teams
- Demonstrated ability to develop, coach, and mentor staff
- Review/approve validation protocols and reports
- Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards
- Responsible for reviewing and approving investigations, standard operating procedures, batch records, protocols, etc. as needed
3
Experience For Associate Director, Quality Assurance GCP Resume
- Excels at working in a challenging, fast paced, and dynamic environment, enabling project teams to meet aggressive goals and timelines
- Expertise in testing across browsers, email, online advertising and mobile apps
- Extensive involvement leading complaint investigations and trending product complaint data
- Assess risks and benefits to make timely, sound decisions and accept responsibility for meeting and/or exceeding objectives
- Provide QA support for global, harmonized Quality Systems, working on cross-functional teams
- Provide quality as well as technical input to Biologic Drug Substance and Drug Product manufacturing Product Teams
- Audit manufacturing and QC records/documentation
4
Experience For Associate Director Quality Assurance GLP Resume
- Regularly interact with Cerus management regarding quality matters and communicate compliance requirements at all levels
- Exercise independent judgment and select methods and techniques for obtaining solutions
- Provides GMP expertise of aseptic drug product filling operations in a biologics facility
- Coach, mentor and develop team members supporting their personal development and also colleagues
- Maintain knowledge of regulatory agencies’ change in regulations/guidelines, current trends, and areas of focus
- Assures the development and maintenance of a Quality Agreement with the EP’s. Acts as the Quality expert on Merck's behalf regarding contractual negotiations and provides input into the development of commercial contractual agreements with the EP on quality related terms
- Has responsibility for Quality assurance and control functions to include direct support to EP’s, coordination and oversight for product testing, as well as other relevant components as determined by applied calibrated Quality oversight
5
Experience For Associate Director Quality Assurance Resume
- Provides support to the EP’s to facilitate and validate new product introductions
- Experience with offshore QA teams
- Familiarity with multiple functional suites and software packages for requirements and QA (JIRA, HP, etc.)
- Overall Quality Assurance
- Proficient in MS Word, Excel, and Power Point,
- Carries out managerial responsibilities in accordance with the organization’s policies, procedures, including safety rules and regulations and state, federal and local laws
- Collaborate with quality management to establish technical quality agreements with critical suppliers, CMO’s, service providers, test laboratories, and distributors providing critical materials and/or services to Intarcia
- Responsible for presenting Intarcia’s CMO oversight and qualification program to regulatory agencies including interacting with regulatory agencies during inspections on supplier QA related matters
6
Experience For Associate Director, Quality Assurance Resume
- Conduct external audits of critical vendors and CMO’s
- Responsible for the management and development of direct and indirect reports on multiple shifts to ensure efficiency, effectiveness and continuity of departmental operations
- Provides training and mentorship to less experienced members of QA staff
- Ability working with multifunctional, global teams. Multi-site management experience helpful
- Responsible for collaborating with appropriate departments to resolve technical and compliance issues
- Responsible for overseeing manufacturing deviations and quality systems to ensure compliance with cGMP’s, SOP’s, company practices and procedures and governmental regulations
7
Experience For Associate Director, Quality Assurance GMP Resume
- Responsible for overseeing batch record issuance, review and release, finished goods batch record review, , in-process record review, sampling and sample delivery, change controls, CAPA’s , and batch record database information management
- Supports timely release of clinical Biologics (DS, sterile DP, and secondary packaged clinical supplies)
- Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable
- Serves as member of project team with participation in the applicable forums, providing GCP compliance advice and guidance to customers, to achieve continuous quality improvement and effective quality controls
- Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice and QA expertise
- Contributes to the QA strategy and support s QA goals for the aligned studies/countries in a given TA/Region
- Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QA assessments and to support the implementation of associated risk mitigation strategies
- Manages coaching, training, development, and retention of subordinates
- In alignment with risk assessments, supports the identification audit substrate for scheduling, as appropriate
8
Experience For Associate Director, Quality Assurance, CMO Resume
- In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements)
- Be able to analyze and leverage quality indicators and data to identify potential trends and risks, and perform root cause analyses to enable principles of knowledge based auditing within respective TA and/or region
- Support Significant Quality Issues management for aligned studies, including assessment of potential root causes and remediation (corrective and preventative actions)
- Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head
- Promotes standardization of auditing approach within QA
- Responsible for quality assurance of LMF packaging and inspection operations
9
Experience For Associate Director, Quality Assurance GCP Resume
- Understands and assures conformance to regulations, applicable to several sections or departments. Interfaces with regulators during inspections
- Thorough knowledge of the manufacturing operations, applicable procedures, specifications, regulations and standards
- Collaborate with cross-site QA teams to provide leadership and CMC support for Biologic Drug Substance and Drug Product manufacturing
- Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies
- Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally
- Provide inspection management support as appropriate
- Acts as a strong technical resource and is called upon to resolve GCP issues based on knowledge of relevant SOPs (Standard Operating Procedures), GCP, PV regulations and guidelines as well as local regulations
- Routinely suggests new audit techniques/aids in areas of technical expertise
10
Experience For Associate Director Quality Assurance GLP Resume
- Design and actively participate in special assignments on various project teams and work streams as determined by QA management
- Ensures the work climate/culture within QA, exemplifies the MSD Leadership behaviors
- Relevant pharmaceutical experience (i.e., drug development, clinical and/or non- clinical research, regulatory compliance, clinical study monitoring or Pharmacovigilance) including at least 3-5+ years previous clinical Quality Assurance experience conducting a broad range of audits
- Contributes to the QA strategy and supports QA goals for the aligned studies/countries in a given TA/Region
- Manages the QMRI activities for the LA Plant (raw materials, intermediate materials, finished products and retention samples
- Implements quality systems procedures
- Develops budget for department and ensures adherence to the budget
List of Typical Skills For an Associate Director, Quality Assurance Resume
1
Skills For Associate Director, Quality Assurance GMP Resume
- Demonstrated strength in management, written and oral communication, leadership, and project management skills
- Strong skills to grasp business domain knowledge to ensure business stakeholder discussions are fruitful
- Excellent facilitation, negotiation & communication skills (verbal & written)
- Min. 10 years experience in Quality, Technical Operations, related Business Operations or GMP regulated environment, experience in sterile manufacturing
- Substantial experience in general IT experience including development, software implementation and business/systems analysis
- Proven, strong analytical and technical troubleshooting abilities
- Broad quality experience in manufacturing of clinical trial materials, Analytical Development, Quality Control and Validation
2
Skills For Associate Director, Quality Assurance, CMO Resume
- Time Management- Ability to multi-task and manage time efficiently and effectively
- Lead a group of 20-30 employees effectively
- Experience with Good Laboratory Practice regulations and clinical bioanalytical analysis (GCLP)
- Superior interpersonal skills, ability to work with all levels of employees and management across all functional areas
- Creative Thinking - Strong ability to operationalize ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking
- Experience with auditing data from anti-drug antibody, neutralizing antibody, and cell based assays is required
- Experience performing SDLC on standalone instruments
3
Skills For Associate Director, Quality Assurance GCP Resume
- Good understanding of the pharmaceutical industry and regulations applicable for a contract
- Experience leading a team GLP Quality Assurance professionals
- Experience or sound understanding on quality assurance process followed under the software development lifecycle
- Experience in working as Quality Assurance Manager or as Test Manager for waterfall and agile programs
- Work in a fast paced environment with possible dynamic priorities without compromising quality
- Experience in Quality Assurance Operations Management [and] 4 years in Operations, Research and Development or Consulting
4
Skills For Associate Director Quality Assurance GLP Resume
- Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820
- Relevant technical experience and min 5 years Managing people
- Demonstrates a customer driven approach to ensure internal customer expectations are met/exceeded
- Lead off-site discussion and review of supplier performance and Current Good Manufacturing Practice (cGMP) compliance
- At least four (4) year floor experience in a pharmaceutical manufacturing facility under a GMP environment
- Six (6) years of leadership and management experience in Quality functions
- Experience in the development of innovative and action oriented quality programs are critical
- Expert knowledge of FDA and OECD Good Laboratory Practice regulations and industry accepted interpretations
5
Skills For Associate Director Quality Assurance Resume
- Knowledge of computer system validation lifecycle is desirable
- Autonomy - Demonstrated ability to work independently
- Experience in the use of test tools, particularly HP Application Lifecycle Management
- Promoting “Shift Left” thinking every day with project leaders
- Sleuthing throughout the development process for risks, not just when “testing"
- Working knowledge of auditing concepts and procedures
- Performing level of the following capabilities in the QA capability framework
- Influencing- Ability to influence and negotiate with key stakeholders
- Leading off-site discussion and review of supplier performance and cGMP compliance
6
Skills For Associate Director, Quality Assurance Resume
- Relentless about producing quality software and finding defects
- Always seeking newer and more efficient ways to run a QA department
- Sound understanding of software development lifecycle
- Knowledge of testing both custom and packaged application
- Broad understanding of customer/business relationship and environment
- Serves as a Liaison for QA activities supporting regulated activities within Merck sites (domestic and international) and contract facilities worldwide
7
Skills For Associate Director, Quality Assurance GMP Resume
- In Quality, preferably Quality Assurance
- Promote a culture of continuous improvement and respectfully challenging the status quo, while driving departmental/regional strategies that align with our organization's long term strategy
- Strong ability to motivate teams to embed quality by design through the life cycle of the project
- Leadership - Act independently to make key timely decisions with limited oversight by management
- Provide support as request to enable the development and implementation of any new Corporate Quality Initiatives
- Engage and collaborate with the team on initiative goals and strategy
- Lead subteams to provide deliverables for Initiative implementation
8
Skills For Associate Director, Quality Assurance, CMO Resume
- Cultural Agility - Demonstrates ability to work in a culturally diverse environment. Consistently takes a tactful approach to global thinking and cultural sensitivity. Demonstrates a mutual respect for differences
- Logic and analytical skills- Uses rigorous logic and methods to solve difficult problems with effective solutions. Probes all sources for answers; can identify hidden problems. Is excellent at analysis. Goes beyond the obvious and seeks novel approaches to complex situations
- Communications- Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats
- Independently and directly represent Takeda to make decisions on acceptability of Third Party Manufacturers’ and Packagers’’ quality programs and ongoing activities
- Establish TPUSA QA expectations for third party manufacturing and packaging vendors, perform strategic systems reviews and coordinate risk/benefit analyses of supplier processes and systems to assure compliance with cGMP’s and Takeda Quality System expectations
- Develop and maintain a broad network of relationships within Takeda’s global environment. Represents Takeda and senior management at corporate and regional meetings and, as necessary, with Regulatory Agencies, industry groups and business partners
- Managing staff and equitably distributing work to ensure timely review of batch documentation and disposition
9
Skills For Associate Director, Quality Assurance GCP Resume
- Generating and/or reviewing excursion reports to assess compliance and disposition decisions
- Create and cultivate working relationships and networks across the organization, building agreements that lead to mutually beneficial outcomes
- Supplier oversight via initiation, monitoring and completion of change controls related to Quality topics
- Thoughtfully analyze information and data to make key decisions. regarding potential risks associated with product quality or regulatory violations
- Able to direct, motivate, support, and develop employees who are fully engaged in pursuing organizational goals and their individual career aspirations
- Lead off-site discussion and review of supplier performance and cGMP compliance
- Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors
- Seeks out all resources when selecting methods and techniques for obtaining results
10
Skills For Associate Director Quality Assurance GLP Resume
- Acts independently and proactively to direct method and procedure for problem resolution
- Develop and implement strategic approaches to batch review and disposition processes for drug substances and products
- Work in a fast paced environment with aggressive project timelines
- Able to broadly apply GMP principals to quality assurance issues, systems and goals
- Support regulatory submissions from early stage to commercial launch
- Manage budgets and react appropriately as project needs change
- Experience in implementation and administration of quality systems to support production of clinical trial materials for Biologic Drug Substance and Drug Product manufacturing, technical transfer, analytical method development, validation and transfer
- Knowledge of a production/technical field such as pharmaceutical analysis at various stages of
- Use common software applications (Word, Excel) to create required records and reports
List of Typical Responsibilities For an Associate Director, Quality Assurance Resume
1
Responsibilities For Associate Director, Quality Assurance GMP Resume
- Manage team of QA product managers and associates to provide QA representation, guidance, leadership, and direction to product development teams for both Drug Substance and Drug Product
- Review, approve and perform investigations and provide guidance for CAPA related to non-compliance situations using creative problem-solving skills
- Thorough understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- Experience in pharmaceutical/biotech industry, with at least 10 years directly supporting aseptic operations
- Experience independently managing GMP Quality Assurance operations to support clinical and/or commercial project teams
- Closely collaborate with appropriate business/operations areas to ensure that effective and robust Quality systems and processes are in place
- Manages and leads effective teams
- Lead the coordination of significant quality events including fact finding, investigation support, coordination of clinical quarantine and recovery actions
2
Responsibilities For Associate Director, Quality Assurance, CMO Resume
- Oversees clinical trial material manufacturing and packaging activities
- Accomplishes staff results by communicating updated organizational information, job expectations and supporting their work
- Works with QA lead to manage regulatory inspections as assigned including provided training to the organisation as needed
- Ensure timely review and approval of all Quality Assurance activities including but not limited to batch disposition of production records
- Lead a team of direct reports. Actively manage team’s workload and provide coaching and development to staff
- Proficient working knowledge of US FDA regulations, cGMP guidelines and industry standards
3
Responsibilities For Associate Director, Quality Assurance GCP Resume
- Oversees preparation and reviews documentation, including batch records, protocols and reports
- Helps generate schedules and coordination of manufacturing activities
- Keeps team current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
- Focus on driving continuous quality improvements. Initiates and revise SOPs and Policies as necessary
- Interacts with customers, peers and upper management to resolve issues and gain the cooperation of others
- Work closely with employees to mentor, guide and support daily product activities
- Review and approval of regulatory documentation and submissions
- Maintain, manage, and enhance quality systems to ensure they conform to Alkermes quality practices and international regulatory compliance requirements
4
Responsibilities For Associate Director Quality Assurance GLP Resume
- Provide support for investigations into variances and quality issues and are able to assure that proper changes are made to guarantee continued and consistent product quality
- Schedule, personally conduct and/or manage GMP QA Supplier Quality audits
- Support implementation of new software Quality Systems for continuous improvement
- Participate in Quality Systems continuous improvement projects for example; change control, data integrity, deviation and CAPA management
- Works interdepartmentally and across sites as a team player to achieve goals
- Develop, implement or enhance phase appropriate Quality Systems to support Alkermes’ development programs
- Assure compliance to Alkermes Quality Systems and regulatory requirements for the manufacture of clinical trial supplies through all phases of development
- Assure staff is aligned with Alkermes’ goals and objectives to support development products
5
Responsibilities For Associate Director Quality Assurance Resume
- Oversee assigned quality assurance activities related to FDA regulations and ISO standards for medical devices, pharmaceuticals, and biologics
- Perform supplier quality audits and facilitate corrective actions
- Interact with suppliers on quality matters
- Host/support inspections of facilities and contract organizations by national and international regulatory agencies and notified bodies
- Identify, organize and adapt implementation of new state/local/federal/international regulations and standards
- Audit study reports and raw data for compliance with protocols, SOPs and regulations
6
Responsibilities For Associate Director, Quality Assurance Resume
- Proactively communicate concerns and/or risks to manager or Sr. Management when appropriate
- Establish and maintain collaborative relationships with cross-functional teams
- Understanding and working knowledge of GMP compliance including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary use
- Evaluation and/or disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of Merck and compliance with all governing regulations
- Coordinate and provide guidance in the preparation of procedures, processes and quality improvements where warranted
- Ensure reliability of clinical supplies availability for Merck clinical trials via daily operational management for the clinical finished goods disposition and supporting activities, with the associated potential for high impact to the development portfolio
- Assure capacity planning, scheduling and operational processes and systems are managed and enhanced for clinical supplies disposition and associated activities
- Support the development and execution of quality strategies, improvement initiatives in line with business drivers and objectives to ensure and enhance the robustness of our compliance posture whilst streamlining processes and procedures
- Provision of in-depth technical/quality expertise including identification of trends and/or potential compliance gaps and proactively leading the resolution of significant issues affecting quality in areas of expertise
7
Responsibilities For Associate Director, Quality Assurance GMP Resume
- Assist, as part of the Clinical Supplies Quality Leadership Team, the development of strategic plans and translates and defines these in terms of related work processes and practices
- Support development of overall strategy and management of highly effective, efficient Quality Systems. Continuously review Biogen procedures and practices to ensure quality standards are compliant with regulatory requirements
- Management of all domestic and international regulatory agency and strategic partner site inspections. Assures appropriate resolution of inspection/compliance commitments
- Provide counsel to the Site Operational Leadership team with respect to GMP compliance matters
- Direct investigations and resolution of all exceptions and ensure that appropriate, timely corrective and preventive actions are implemented and documented
- Assist in implementation of Global Quality Assurance strategic initiatives
- Develop, monitor and report status of KPI compliance metrics including product release, exceptions, and CAPA identifying adverse trends and potential risk for the organization
- Quality oversight of GMP operations in support of commercial and development/clinical manufacturing, testing and packaging operations, including any post-marketing QA activities (e.g. product complaints)
- Reviews and approves GMP documentation such as batch records, protocols and reports
8
Responsibilities For Associate Director, Quality Assurance, CMO Resume
- Leads investigations into Deviations, OOS/OOT
- Independently processes Product Complaints
- Promotes Ironwood’s quality mission, vision and strategy
- Interfaces with internal and external cross-functional teams
- Negotiates the content of Quality Agreements
- Authors, reviews and/or approves Ironwood SOPs
- Subject matter expert on internal and external GMP audits
9
Responsibilities For Associate Director, Quality Assurance GCP Resume
- Knowledge of the pharmaceutical development process and key Quality Assurance roles and responsibilities in the drug development lifecycle
- Highly proficient in the use of electronic systems such as Quality Management Systems, Microsoft Office and Microsoft SharePoint
- Able to perform various tasks in a disciplined, consistent manner under minimal supervision
- Accommodates travel, approximately 10%
- Manufacturing and packaging technical support for Depomed’s commercial products interfacing Commercial, Quality Assurance, Quality Control, Clinical, Regulatory
- Oversees the development and manufacturing of drug products and/or transfer of development activities with CMO
10
Responsibilities For Associate Director Quality Assurance GLP Resume
- Work with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements. Support manufacturing investigations and regulatory submissions
- Efficiently manage all activities within resource constraints while complying with all of our organization's policies and regulatory requirements
- Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within our organization
- Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide GCP and QA expertise
- Responsible for employee development/guidance and conducting performance reviews in a timely and objective manner
- Attend seminars, shows, lectures, etc., that are industry or job related
- Manage the audit and/or approval of GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer, facility and/or equipment qualification. Ensure compliance with regulatory and our organization's requirements. Evaluate deficiencies and assess impact on compliance status
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