Senior Manager, Quality Assurance Resume Sample
Tremayne Johnston
4146 Dustin Lights,
Boston,
MA
+1 (555) 764 5804
Work Experience
Senior Manager, Quality Assurance
06/2015
-
PRESENT
Houston, TX
- Lead Servicing’s existing Quality Assurance function (20+ FTE focused on Loan File Reviews) and build a small team of QA professionals to continuously enhance process outcomes and customer experience. Provide overall staff management for team, including recruiting, performance coaching and developing team members
- Provides leadership and direction to a team of design assurance engineers, label copy analysts, and graphic designers to effectively support the business
- Direct management of Design Assurance Engineers and Label Copy Development personnel
- Design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history file maintenance
- Regulatory compliance: Regulatory compliance projects/initiatives, as assigned, in accordance with FDA QSR 21 CFR Part 820 (CFR 210/211 desired), ISO 13485, CMDR, MDD, and J-PAL
- Design assurance risk management: Assure that appropriate risk management tools (i.e. FMEA's, PFMEA’s, etc.) are utilized for all programs and projects and that the tools used are consistent with applicable regulatory standards and industry practices, including ISO 14971
- Ensures alignment of overall key labeling statements, key messages, and formats across the business
- Provides leadership regarding the development and implementation of labeling in regards to the regulatory strategy and documentation for marketed products and products in development
Senior Manager Quality Assurance
08/2009
-
05/2015
Houston, TX
- Accountable for the timely preparation and content of product labeling
- Responsible for escalating labeling issues to upper management, evaluating regulatory risks and developing mitigation plans in close cooperation with Senior Management
- Provides advice, counsel, and direction on labeling impact/requirements for labeling concepts during early stage product development
- Ensures that labeling adequately meets end user needs and contains all clinically relevant information for successful direction for the given procedures
- Communicates changes in regulations and practices to the organization effectively and in a timely manner and aids in the development of plans to address these changes
- Provides Technical File and Design Dossier management assistance to Regulatory Affairs and supports maintenance of these documents
- Initiates and directs Corrective and Preventive Actions to address problems/issues relating to process and/or product quality
- Assists the BU and Plant Management Representatives in preparation for internal audits and third party audits (i.e. FDA inspections, notified body audits) and supports the effective closure of findings resulting from such audits
Senior Manager, Quality Assurance & Euar
12/2002
-
05/2009
Philadelphia, PA
- Displays strong ability to make difficult and/or unpopular decisions
- Practices strong leadership to influence teams to support and implement decisions and strategies
- Develops skills/capabilities of direct reports by creating challenging learning environments and creating stretch goals. Serves as a resource and support for the team’s development efforts
- Effectively provides both appreciation and constructive feedback in a timely manner to support growth and development
- Drives strong cross functional collaboration and ensures team goals are aligned to achieve business goals and objectives
- Develops and implements plans to meet/exceed goals, providing clear direction and motivation focused on attaining goals and objectives
- Leverages relationships with key internal/external customers to support business needs, opportunities, and challenges
Education
Palm Beach Atlantic University
1996 - 2001
Bachelor's Degree in Computer Science
Professional Skills
- Demonstrates audit and investigation skills, and report writing skills
- Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
- Excellent communication and analytical skills, including strong ability to identify and solve ambiguous problems
- Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment
- Excellent analytical skills (Problem Solving, Critical thinking)
- Very strong at effectively prioritizing and executing tasks, even while under pressure
- Strong leadership, negotiation, teamwork, technology and problem-solving skills
How to write Senior Manager, Quality Assurance Resume
Senior Manager, Quality Assurance role is responsible for analytical, interpersonal, training, advanced, organization, organizational, consulting, database, technical, leadership.
To write great resume for senior manager, quality assurance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Manager, Quality Assurance Resume
The section contact information is important in your senior manager, 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 Senior Manager, Quality Assurance Resume
The section work experience is an essential part of your senior manager, 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 senior manager, 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 senior manager, quality assurance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Manager, Quality Assurance resume experience can include:
- Excellent communication skills and great organizational skills
- Demonstrates excellent leadership and management skills. Proven ability to function within a matrix organization
- Excellent oral and written communication skills. Proven track record of developing and coaching teams
- Advanced oral and written communication skills; ability to communicate with management, peers and subordinates effectively
- Strong investigative and analytical skills; demonstrated problem-solver
- Excellent conflict management and consulting skills
Education on a Senior Manager, Quality Assurance Resume
Make sure to make education a priority on your senior manager, 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 senior manager, 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 Senior Manager, Quality Assurance Resume
When listing skills on your senior manager, 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 senior manager, quality assurance skills:
- Good written and verbal communication skills in English are essential and also good verbal communication skills in Swedish is highly appreciated
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
- Excellent conflict management and consulting skills is required
- Work as a team member and to work collaboratively with strong listening skills
- Good stakeholder management and presenting skills
- Effective cooperation and influencing skills, ability to work independently
List of Typical Experience For a Senior Manager, Quality Assurance Resume
1
Experience For Senior Manager Quality Assurance Resume
- Proven ability to deliver results effectively, set expectations and identify risks to delivery
- Demonstrated experience in mentoring and coaching, with ability to motivate teams to reach a common goal
- Decision Making (Essential) Demonstrates good judgment and decision making
- Demonstrated experience or knowledge of performing and managing quality assurance activities for web services
- SAP – Serve as an expert SAP user. Apply skills to maintain and improve current system, provide training to users, create master plans, etc
- Team oriented with mentoring skills
2
Experience For Manager / Senior Manager, Quality Assurance Resume
- Experience with project management or testing, or equivalent, experience
- Advanced skills at budget creation, forecasting and budgetary adherence
- Demonstrated experience leading a team of five to 10 testers
- Experience in Quality and Regulatory Compliance function or equivalent experience
- Demonstrated ability to build strong and sustainable relationships with internal and external partners and stakeholders
- Exceptional organizational skills and attention to detail to manage multiple simultaneous projects
3
Experience For Senior Manager, Quality Assurance & Euar Resume
- Working knowledge of drug development and strong knowledge of operations in an aseptic processing facility required
- Being the main point of contact for Process Validation topics
- Leading critical quality review of design requirement rationales, test methods, and test method validation
- Experience hiring, mentoring, goal-setting, correcting and reviewing staff
- Experience in Quality Assurance, Manufacturing, Supply Chain, or Engineering role responsible for hardware conformance and compliance
- Experience and understanding of various types of testing
4
Experience For Senior Manager Quality Assurance & Risk Management Resume
- Experience building and implementing strategies is required
- Experience in Managing and leading on-site/off-shore teams
- Experience building and maintaining relationships with customers, clients, and colleagues
- Highly skilled and practiced at working with higher mathematical concepts, including probability and statistics
- Experience in conducting testing function in an Agile development environment
- Knowledge of and experience with web and marketing technology such as Adobe AEM/CQ, Adobe Marketing Cloud, Eloqua and Salesforce
- Experience working with remote, yet integrated, development and quality assurance resources
- Effective and timely communication with Division RAQA leaders of any potential field actions and product holds being investigated,
- Strong knowledge of the pharmaceutical industry regulations applicable to API manufacturers, including FDA regulations
5
Experience For Senior Manager Quality Assurance Engineering Resume
- Train new and existing less experienced QA members
- Ensures that effective corrective and preventive actions are implemented in a timely manner to prevent reoccurrence of quality events during batch production
- Creates and facilitates effective GMP training to the Operations team
- Demonstrated ability to follow detailed directions in a laboratory / manufacturing environment
- Demonstrated ability to provide statistical guidance in the sampling activities to support product and process quality improvement
- Drug substance / Drug Product Quality manufacturing experience
- Experience and understanding of full lifecycle of product development
6
Experience For Senior Manager, Quality Assurance Compliance Resume
- Release of incoming goods
- Strong understanding of QA concepts, methodologies and tools in data domain
- Strong background in Quality Assurance and Testing
- Strong background in working with stakeholders of multiple disciplines, cross-functional teams, and the business
- Strong proficiency in determining company’s business goals and objectives with ability to devise and implement strategy to achieve targets
- Proven track record of successful change management accomplishments, implementing and management continuous improvement and cost reduction programs
- Six Sigma Black Belt certification and/or Lean Manufacturing experience highly desired
7
Experience For Senior Manager, Quality Assurance & Testing Resume
- Provides support and counsel to business functions who are incorporating customer experience strategies into our day-to-day customer relationships
- Knowledge of regulations and standards affecting IVDs strongly desired
- Experience with automated testing, test management tools and best practices
- Establish priorities and align strategies and projects to the Corporate, Business, Department, and QA group objectives
- Evaluate subordinates’ performance against those goals and priorities
- Serve as QA representative on cross-functional project teams such as tech transfer, validation, computer systems, process improvements, and investigations
- Experience in .NET/C# development
- Demonstrated knowledge of Web technologies (HTTP, HTML, JavaScript, CSS, etc.), data formats (XML, JSON, YAML)
8
Experience For Senior Manager Quality Assurance & PMO Standards Resume
- Demonstrated knowledge of APIs and appropriate test automation
- Demonstrated knowledge of Selenium and other Test Automation frameworks
- Demonstrated knowledge of Acceptance Driven Development (ATDD)
- Demonstrated knowledge of SQL and Relational Database structures
- Experience with own brand label/private label regulatory requirements
- Educates internal staff on customer experience concepts, value proposition, and related processes
- Experience in a high volume and fast-paced structured environment
9
Experience For Senior Manager Quality Assurance Testing Resume
- Direct supervisory experience
- Experience in a high tech production environment as a QP
- Overall experience in a regulated industry – Medical Devices, Pharmaceutical or equivalent
- Experience in Management position in Quality Assurance or equivalent position
- Two or more years of AgileWeb/software development experience
- Two to three years of test automation experience
- Three or more years of quality assurance/test management experience
- Demonstrated ability to identify, understand and drive the resolution of complex critical issues
- Proven ideas, that when implemented, improved quality processes
10
Experience For Senior Manager, Quality Assurance Process Resume
- Work with operations to establish good manufacturing practices and improve quality culture
- Understanding of best practices for securing applications and application data
- Being the point of contact for other Quality functions within the Biogen network regarding the release and distribution of manufactured batches
- Providing support regarding pharmaceutical issues to clients and employees
- Working to remain an active learner in all automation technologies related to application testing
List of Typical Skills For a Senior Manager, Quality Assurance Resume
1
Skills For Senior Manager Quality Assurance Resume
- Excellent interpersonal skills (relationships, influence, negotiation, teamwork)
- Excellent organizational, interpersonal, written and oral communication skills are required
- Strong presentation skills - both presentation development (Power Point) and presentation delivery
- Effective management and communication skills
- Prior experience working for a Contract Manufacturing Organization
2
Skills For Manager / Senior Manager, Quality Assurance Resume
- Advanced troubleshooting and problem-solving skills
- Experience with understanding and implementing automation solutions and frameworks . Experience on Web Service virtualization
- Ruby Scripting experience or At least 3 years of Object Oriented software development experience
- Related quality assurance experience, including supervisory experience
- Software quality assurance experience, including 2 years of people management or lead experience
- QA Engineering experience OR At least 6 years of combination experience in QA and Development
- Advanced organizational skills; ability to multi-task and coordinate multiple activities in parallel
- Appropriate level communication skills
- Prior hands-on experience with automation tools/frameworks for data testing
3
Skills For Senior Manager, Quality Assurance & Euar Resume
- Independently identify and resolve complex problems utilizing functional and technical skills
- Work related experience in food industry, food manufacturing experience desired
- Operate in a fast-paced environment and prioritize activities as needed
- Communicate effectively at all levels within the organization and appropriate external parties
- Experience in Mortgage Servicing or in Lending Operations (e.g., Mortgage Processing, Auto Lending, etc.) or Call Center management
- Experience in Consumer Finance, Lending, Leasing or Banking Operations
4
Skills For Senior Manager Quality Assurance & Risk Management Resume
- Experience managing other managers, individual contributors, giving feedback and facilitating work
- Strong understanding of Risk Based Testing approach to assign appropriate QA time and resources for testing
- Demonstrates success working with others, learning from others, and building consensus to achieve established goals
- Proven ability to develop and implement QA processes, and developing /Managing software QA programs and teams
- Experience building and implementing test strategies and test plans is required
- Experience in establishing and maintaining healthy relationships with business and technology partners is required
- Experience with project management methodologies including agile methodologies and supporting techniques
- Experience in auditing food manufacturing facilities
5
Skills For Senior Manager Quality Assurance Engineering Resume
- Experience with testing at least one of the following stacks: iOS (Objective-C or Swift), Android (Java), NodeJS
- Experience with testing and pulling logs from a wide range of mobile and OTT devices
- Experience implementing and meeting ISO 9001:2015 requirements
- Experience working with DevOps teams and understanding of DevOps practices, tools, solutions and implementations
- Experience working in a quality, sales, service, process improvement or customer retention based role in a call centre or retail environment
6
Skills For Senior Manager, Quality Assurance Compliance Resume
- Experience in automated testing towards mobile applications
- Experience in a broad range of food manufacturing categories desired
- Experience developing medical capital equipment is required
- A strong understanding of Design Control requirements for new product development is required
- Experience managing quality assurance teams of 4+ people who are geographically dispersed
- Experience in pharmaceutical or biotech manufacturing environment
- Experience in managing all aspects of Quality Management System, Operational Excellence activities
- Experience with user-level automation frameworks and scripting via Java, Javascript, Perl or Python
7
Skills For Senior Manager, Quality Assurance & Testing Resume
- Experience in implementing core business related industry standards such as ISO 20000-1, ISO 27001 and Information Technology Infrastructure Library (ITIL)
- Possesses strong understanding of financial information and metrics as they relate to the company and industry
- Experience in problem solving and organizational development
- Experience working with Regulatory bodies
- Significant Quality experience at Aseptic Manufacturing facilities
8
Skills For Senior Manager Quality Assurance & PMO Standards Resume
- Experience in a QA management role managing internal resources
- Experience leading offshore technology teams
- Good understanding of Environment Management, Release Management and overall quality gates is highly desired
- Experience in a higher end retail sales and manufacturing environment
- Previous production application support experience would be an asset
- Three years’ experience in Quality, Compliance, Internal Audit, or related control function
9
Skills For Senior Manager Quality Assurance Testing Resume
- Experience in leading QA sprint teams
- Experience in quality tools ALM, QC, Selenium, QTP and Automation Suites
- Experience in business processes
- Experience in Withdrawal/Recall events
- QA leadership experience with a cross functional team
- General experience in this field
- Quality experience, specifically Automotive background, supplier management, etc
- Experience with Microsoft Office products, in particular Microsoft Project is required
10
Skills For Senior Manager, Quality Assurance Process Resume
- Experience with Microsoft Office products and Microsoft Project is required
- Develop strong relationships with customers and plant level teams
- HPQC/ALM tool administration experience- Mandatory
- Water fall & Agile methodologies experience - Mandatory
- MS Project experience - Mandatory
- Strong knowledge of QA concepts and methodology
- Min. 10 years of GMP or GDP experience for Medicinal Products
- Quality and Logistics experience
- Experience doing development and testing on data warehouses, MDM, Data Lakes required
List of Typical Responsibilities For a Senior Manager, Quality Assurance Resume
1
Responsibilities For Senior Manager Quality Assurance Resume
- Participate in the process to establish, communicate and manage objectives, strategies and plans for the Testing area of UAT, ensuring quality principles are adhered to in a ‘speed-to-market’ culture
- Detail-oriented, analytical with excellent critical-thinking skills
- Develop staff skills, abilities, and experiences for succession planning
- Prior experience related to quality systems in technology transfer, scale up and validation
- Manual test experience and 3+ years automation test experience on desktop web, mobile web, and mobile apps
2
Responsibilities For Manager / Senior Manager, Quality Assurance Resume
- Influence and work effectively cross-functionally
- Can effectively maneuver through political situation and anticipate roadblocks
- Pharmaceutical industry experience, with at least 3 years auditing experience
- Manufacturing of cell based products as well as knowledge of Good Tissue Practices is required
- Managing and prioritizing the team's workload in accordance with organizational and departmental goals
- Providing guidance to staff to interpret changing priorities, processes and regulatory requirements
3
Responsibilities For Senior Manager, Quality Assurance & Euar Resume
- Industry experience, including at least 3+ years of hands-on testing or test automation and 7+ years as a quality assurance manager
- Experience managing a QA team
- Experience with early phase clinical drug substance/drug product manufacturing is required
- Good understanding of risk assessment and risk mitigation implementation in pharmaceutical industry
- Experience and understanding of AS9100 Quality System requirements and the intention of systems documentation
- Experience managing external suppliers, blood banks, and plasma centers
- Build the organization's capabilities to create effective quality engineering at all levels
- Demonstrates working knowledge of quality assurance systems, methods and procedures
4
Responsibilities For Senior Manager Quality Assurance & Risk Management Resume
- Experience in Medical Device design and manufacturing
- Develop effective data collection and reporting systems to meet regulatory requirements and management information needs
- Experience working with Quality systems is required
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
- Experience in a QA environment in a leadership role
- Thoroughly tests software to ensure proper operation and freedom from defects prior to implementation. Documents and works to resolve all problems
- Operate in a fast-paced, multi-disciplinary industrial environment
5
Responsibilities For Senior Manager Quality Assurance Engineering Resume
- Demonstrated ability and commitment to continual improvement
- Experience managing and creating test automation frameworks
- Experience testing embedded systems and/or mobile consumer electronics devices
- Diagnostic industry experience required
- People management or leadership experience is required
- Behaving and driving achievement in accordance with NP Medical’s PRIDE values
- Implementating and maintaining the NP Medical Quality Management System in compliance with FD&C Act, 21CFR820, MDD, ISO13485, CMDR
6
Responsibilities For Senior Manager, Quality Assurance Compliance Resume
- Managing the Site Management Review process
- Managing the Inspection Readiness and Inspection Management processes at the Solothurn site
- Developing staff and conduct mid-year and annual reviews of staff
- Recognizing and Rewarding accomplishments in accordance with NP Medical’s PRIDE values and behaviours
- Identifying opportunities for improvement and developing processes to ensure regulatory compliance and process robustness
- Championing ISO 14971 Risk Management compliant processes
- Leading the development of SOPs and work instructions and associated quality tools to improve product quality and to increase work efficiency
- Translating strategic goals into group and individual performance objectives
7
Responsibilities For Senior Manager, Quality Assurance & Testing Resume
- Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and other statistical modeling
- Define processes and procedures related to system testing, performance testing and load testing of all Compliance applications
- Provides challenging and stretching tasks and assignments to key talent in the organization
- Provide direct QA oversight of GMP facility including Manufacturing, Quality Control, and Facilities
- Collaborates in the technical development, review, and approval of GMP manufacturing production batch records (MBR/MPR) and standard operating procedures (SOP)
- Monitors and ensures QA oversight of manufacturing floor activities during GMP production
- Continually evaluates quality systems supporting GMP manufacturing operations for potential improvements
- Implement new and existing procedures to a new manufacturing site; Author and revise SOP, protocols and work instructions as required
8
Responsibilities For Senior Manager Quality Assurance & PMO Standards Resume
- Five (5) years in a quality supervisory position performing Quality Assurance functions including batch release
- Provide leadership and support to J&J process excellence initiatives including six-sigma, design excellence and lean thinking
- Provide leadership in design and delivery of world class equipment to support refractive and cataract surgery, in meeting and exceeding customer requirements
- Support the Regulatory department in the writing and checking of CMC and related documentation
- Engage with Marketing and Design to ensure that our product packing and appearance meet our strategic goals and promote our brand awareness
9
Responsibilities For Senior Manager Quality Assurance Testing Resume
- Ensure all standard operating procedures and training are documented
- Drive resolution/improvements to implementation through direct contribution or by facilitating working teams
- Lead by being an agent for change and questioning the status quo
- Comfortable with speaking and interacting with inspectors
- Manages contractor resources/employees to a budget supporting test initiatives for capital projects
- Collaborate with Commercial in the routine management of the ATC relationships and Supply Chain for courier qualification and monitoring processes
- Oversight and Support of GMP Manufacturing Activities
- Acts as the primary QA point of contact for Manufacturing when deviations arise on the production floor
- Generates and implements policies and procedures in support of the clinical and commercial manufacturing facility
10
Responsibilities For Senior Manager, Quality Assurance Process Resume
- Generates and evaluates trend reports and metrics to measure key quality attributes in manufacturing operations
- Design and maintains the quality system according to written policies and procedures
- Provide technical direction to team/coaching
- Strategic planning and QA improvement initiatives
- Attend Material Review Board/Distributed Material Review Board meeting as needed
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