QA Senior Manager

In this vital role you will Ensure that all Quality Requirements have been met and DHF is ready for GMP inspections, Inspection Readiness Activities, and Partner Audits. Obtains, reviews, and confirms readiness of documentation for inspections. Develops and documents control strategy/control plan.

• Responsible for providing Quality technical expertise, Quality oversight, and a single point of Quality contact for Combination Product Operations activities. Attends development program meetings as required as part of program working teams. Works cross-functionally with individuals and project teams to ensure success of development project efforts.
• Provide guidance on documentation structures created during development activities. Responsible for identifying proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable regulations and Amgen procedures. Act as QA contact for change controls for projects, and review and approve relevant Design Control documentation.
• Creation and Maintenance of Design History File Index, Device Design Traceability Matrix, Quality Combination Product Plan, and EDO Control Plan, and contribute to Design Control Phase Design Reviews. Provide Quality oversight of Design Characterization, Verification, and Validation activities.
• Ensure adherence to all relevant development final product regulations and standards. Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects.
• Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
• Projects may include secondary packaging, primary container, mechanical, electrical, and/or software as part of the system(s).
• Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and EDO Control Plans. Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers.
• Participate in deviation, CAPA, & Complaint investigations for commercial programs. Participates in audits and inspections, well prepared including all relevant details supported by evidence.
• Collaborate to develop complete formal written responses. Acts as independent reviewer for other combination product program design reviews.
• Partner with CPO to contribute to management review, including topic selection
• Provides quality advice to teams on regulatory strategy. Ensures activities are in line with budget and support evidence-based resource needs. Management, development, and selection of highly qualified staff

NOTE: This role may require working in shifts or extended hours within the same shift

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of quality and/or design space experience OR
• Masters degree and 8 to 10 years of [Job Codes Discipquality and/or design space experience OR
• Bachelors degree and 10 to 14 years of quality and/or design space experience OR
• Diploma and 14 to 18 years of quality and/or design space experience

Preferred Qualifications:

Quality and manufacturing experience in biotech or pharmaceutical industry

Ability to convey and defend quality perspective to various levels of stakeholders

Participate in full audit cycle Ability to interface with Regulators, and articulate knowledge of their process

Ability to respond to RTQs both verbally and in writing

Ability to interpret technical standards, internal requirements, and regulations Bachelors Degree in a Science Field

Leadership skills and the ability to oversee multiple complex projects simultaneously

Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)

Prior experience leading and/or working as part of a combination product launch team

Ability to effectively negotiate a position after taking feedback from multiple sources

Ability to operate in a matrixed or team environment with site, functional, and executive leadership

Understanding of industry requirements/expectations of a QMS

Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

Ability to travel +/- 20% of time to domestic and international Amgen sites.