Senior Manager, Quality Assurance Job Description
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:
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:
Desired experience for senior manager, quality assurance includes:
Senior Manager, Quality Assurance Examples
Senior Manager, Quality Assurance Job Description
- 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
- 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
Senior Manager, Quality Assurance Job Description
- 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
- 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
Senior Manager, Quality Assurance Job Description
- 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)
- 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
Senior Manager, Quality Assurance Job Description
- 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
- 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
Senior Manager, Quality Assurance Job Description
- 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
- 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