Senior Manager, Quality Assurance Job Description
Senior manager, quality assurance
provides guidance for design control and risk management activities as part of new product development core teams to ensure compliance with regulatory (FDA, MDD, JPAL), local, and corporate requirements and best practices.
Senior Manager, Quality Assurance Duties & Responsibilities
To write an effective senior manager, quality assurance job description, begin by listing detailed duties, responsibilities and expectations. We have included senior manager, quality assurance job description templates that you can modify and use.
Sample responsibilities for this position include:
Taking a leadership role in driving change and managing projects related to audit methodology and practices based on QA results, analysis of professional standards, regulatory expectations or reviews, industry best practices and results of internal or external assessments of the IAD
Deliver training to the IAD on matters identified through QA reviews and to educate staff on changes in methodology or best practices
Providing timely on-going support to IAD staff and management including answering inquiries and providing guidance related to QA and audit methodology
Preparation of quarterly reports to communicate to IAD management the results of all completed QAs, including statistics and trends, and audit methodology or training initiatives
Support the annual SOX audit in support of the reliance model agreed with the external auditors, including coaching and reviewing the work of staff performing walkthroughs and control tests, identifying synergy opportunities and coordinating with stakeholders
Interface with DASH team to evaluate and seek opportunities related to the data being reported
Provides pan-enterprise technology vendor quality control and quality assurance to ensure alignment with strategic goals and objectives, and risk appetite
Evaluates vendor technology alignment with DASH and TRAM and makes recommendations and tracks / reports on to completion
Understand contractual terms and conditions, and their technology related implications to the business
Facilitating regular Stakeholder and Vendor sessions to review Technology Alignment Dashboards
Senior Manager, Quality Assurance Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Senior Manager, Quality Assurance
List any licenses or certifications required by the position: ISO, ASQ, CPA, CMMI, QA, CIA, US, 9001, CISA, CFR
Education for Senior Manager, Quality Assurance
Typically a job would require a certain level of education.
Employers hiring for the senior manager, quality assurance job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Computer Science, Technical, Education, Chemistry, Business, Management, Biology, Finance
Skills for Senior Manager, Quality Assurance
Desired skills for senior manager, quality assurance include:
ISO 13485
Auditing practices
CGMP regulations
FDA
CMDCAS
JPAL
MDD
SFDA
Ability to apply GMP in conformance to US
Desired experience for senior manager, quality assurance includes:
Plans, develops and leads QA program improvements
Ability to remain calm under pressure and influence outcomes based on facts and judgments
Ability to make recommendations that may be unpopular
Ability to train, mentor and motivate other partners
Bachelor's Degree in Accounting, Finance, Other Business Related Field or military experience
Oversee the testing and implementation of multiple, complex, organization-wide systems
Senior Manager, Quality Assurance Examples
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Senior Manager, Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior manager, quality assurance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior manager, quality assurance
- Notify management when significant potential compliance issues exist that may impact the supply chain
- Support the Quality team during regulatory inspections related to commercial products
- Manage CMO’s to ensure compliance with the terms of agreements
- Manage outsourced commercial product complaints
- Coordinate with Production, Quality Control, and other departments to ensure Quality compliance and operations at all times
- Provide Quality expertise, advice, and/or assistance across the organization, as required
- The incumbent in this position should expect to travel up to 20%
- Identifying issues to improve the inconsistent policies, processes, standards and systems
- Optimizing Partnership Distribution be more efficient and innovative
- Strengthening Partnership Distribution’ advantages to become efficiency, collaborative and supportive organization
Qualifications for senior manager, quality assurance
- Experience with QA oversight of hardware, software, and systems engineering design and development contracts and engineering services contracts
- Experience with the ISO 9001 standard
- Experience with performing as an ISO 9001 internal auditor
- Broad knowledge and understanding of the Channel Island AML regulatory framework
- Desire to develop technical skills and be
- Experience of managing a team would be an advantage as the role may include supervision of more junior members of the team
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Senior Manager, Quality Assurance Job Description
Job Description Example
Our company is growing rapidly and is looking for a senior manager, quality assurance. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for senior manager, quality assurance
- Provide advice and guidance on the content of business performance reports and the causes of variance
- Works with the Sr Manager, consolidations and reporting PV/RA/CRQA/QA with summarizing worldwide financial plans and results
- Identifies and supports opportunities for process improvements within own activities and stakeholders' operations
- As agreed with Sr
- Plans and ensures goals are met
- Partner with Testing teams to leverage best practices
- Works closely with cross functional teams from internal departments
- Ensuring ongoing compliance with all applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status and performance of company operations, processes and products
- Supporting inspection readiness/management activities and regulatory authority inspections
- Writing statements of work
Qualifications for senior manager, quality assurance
- Experience with DoD contract technical products and services
- Institute consistent quality metrics to reflect software (functional/application) quality overall test performance by assessing post-production root cause issues
- Must have requisite training or certification in medical device regulatory affairs through on-the-job training, seminars, training
- Experience with Phase I thru IV, particularly Phase III
- Preferably two (2) years of clinical quality experience including performing audits and/or inspection readiness
- A Minimum of 10 years’ experience in Pharmaceuticals/Biotech
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Senior Manager, Quality Assurance Job Description
Job Description Example
Our company is looking for a senior manager, quality assurance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior manager, quality assurance
- Maintain regulatory mandated registrations for Del Monte manufacturing facilities and DCs, Bi-annual FDA registrations, Food Canning Establishment Registration, and Process filings for Low Acid Can Food and Acidified foods
- Working knowledge and experience in Retail or Pharmacy sector preferred
- PMP/ITIL certification considered an asset
- Provide leadership and resource management support to Corporate Quality and their designated Affiliate
- Provide internal auditing resource to assess site compliance on a regular basis
- Manage the review and implementation of Quality Improvement/remediation plans for their Affiliate identified through Corporate internal GXP audits
- Provide Quality Expertise and leadership to their designated Affiliate and lead local/regional Quality activities
- Act as Quality liaison between the local operational groups and Corporate Quality for GMP/GXP/PV functions and activities
- Act as Responsible Person (RP) named on the wholesale licence [WDA (H)]
- Ensure that the provisions of the licence are observed in accordance with the Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01)
Qualifications for senior manager, quality assurance
- The Associate Director will have 8+ years of quality experience plus 3 to 5 year’ commercial QA management and leadership experience
- Experience with late-stage products, including licensure and commercial stage
- Experience with regulatory inspections and licensure, national and international requirements
- High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management
- Experience implementing and testing networking and wireless communications protocols
- Regulatory environment has changed massively and we are facing headwinds with increasing capital requirements
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Senior Manager, Quality Assurance Job Description
Job Description Example
Our growing company is hiring for a senior manager, quality assurance. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for senior manager, quality assurance
- Produce test plans and test cases for multiple scenarios
- Challenge assumptions, think about how different users might interact with a proposed solution, and identify strange edge cases
- Lead and perform manual/automated testing
- Lead and perform Unit, Functional, Integration, System and Performance testing
- Lead and collaborate on the creation and management of automated/manual testing for Load, Performance and Stress testing
- Collaborate closely with Analysts and Developers to gain and share functional and technical knowledge
- Informs the definition of “done”
- Manages and coordinates communication around QA efforts within the team and externally
- Manages and coordinates communication with the Business stakeholders about the quality of the software
- Lead QA Steering Team meetings with discussion of corporate quality policies and agreement on any necessary changes
Qualifications for senior manager, quality assurance
- Knowledge of relevant German laws and regulations like German Drug Law, “AMWHV”, Arzneimittelhandelsverordnung and Law on Medical Devices relevant European regulations and directives
- Access to pharmaceutical knowledge as member of respective German trade associations and/or professional industry groups
- Strong negotiation, collaboration, persuasion, communication (written and spoken) and relationship building skills presentation skills
- Bachelor’s degree in associated discipline is required
- Hardware and Software experience in testing and certification of USB audio and/or USB HID products is a plus
- Audio processing and acoustic testing experience is a plus
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Senior Manager, Quality Assurance Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of senior manager, quality assurance. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for senior manager, quality assurance
- Identifying deviations from AMLATF and other Compliance policies and procedures, and providing guidance on significance and materiality to Regional and Territorial Compliance Teams
- Timely tracking and following up with the Territorial Compliance Team on the QA issues identified through the Divisional QA
- Ongoing support for AMLATF control centralization, including oversight of Bridger Regression Testing, 1st level name scanning and transaction monitoring duties and enhanced due diligence on higher risk cases
- Overseeing and supporting the work quality of the FATCA, CRS and Asia Compliance Independent Testing Teams, providing on-site support and guidance where required and ensuring a general high standard of work quality and documentation, in accordance with generally accepted standards
- Occasional support for the GCO QA team
- Minimum 10 years experience managing in a world-class manufacturing environment
- Black Belt Certification considered a definite asset
- Very strong people management and motivational skills
- Lead culture change from productivity driven to quality driven
- Project Management, knowledge of statistical analysis techniques, DOE, Six Sigma/Lean Manufacturing, ergonomic manual assembly workstation design, process flow, material handling, assembly fixture design
Qualifications for senior manager, quality assurance
- Advocate of change
- Experience in construction and engineering management process for aviation sites and terminal facilities
- Undergraduate degree with emphasis in Finance or Accounting or Life Sciences undergraduate / MBA combination
- Experience working with enterprise grade accounting, reporting and ERP systems (Anaplan, SAP, Hyperion)
- Strong analytical skills and formation of data into useful information for Finance and business customers
- Working knowledge of internal controls and J-Sox, IFRS