Quality Assurance Senior Manager

Amgen•Thousand Oaks, CA

About The Position

The Quality Assurance Senior Manager is responsible for quality oversight of primary component suppliers and serves as an integral member of cross-functional supplier teams involving business operations, process development, supply chain, and combination product quality. The role oversees supplier quality relationships from onboarding through disengagement, promotes compliance with global regulatory standards and Amgen expectations, and supports supplier performance through monitoring, site visits, audits, inspections, and continuous improvement. The position may be based on-site in Thousand Oaks, California; Cambridge, Massachusetts; Greenwich, Rhode Island; Tampa, Florida; or Puerto Rico, and is also open to remote associates anywhere in the United States. Up to 20% domestic and international travel is required.

Requirements

Doctorate degree and 2 years of Quality experience, or a master's degree and 4 years of Quality experience, or a bachelor's degree and 6 years of Quality experience, or an associate degree and 10 years of Quality experience, or a high school diploma/GED and 12 years of Quality experience.

Nice To Haves

10 or more years of biotech or pharmaceutical industry experience.
5 or more years of experience overseeing supplier quality.
Experience leading audits.
Technical knowledge related to primary components.
Experience with quality processes and systems such as Trackwise and Veeva.
Experience with quality oversight of primary components.
History of presenting during inspections and audits.
Ability to facilitate and influence senior stakeholders and partners.
Ability to prioritize workload and meet timelines.
Ability to negotiate a strategic position after receiving feedback from multiple sources.
Strong project management, problem-solving, and analytical skills.
Demonstrated ability to lead cross-functional teams and consistently deliver timely, high-quality results.
Ability to collaborate and communicate with others, balance divergent input from partners, and drive issue resolution.
Ability to work in a matrixed or team environment with site, functional, and executive leadership.
Experience managing relationships with external parties.
Familiarity with data and artificial intelligence tools.

Responsibilities

Lead quality oversight of supplier relationships from onboarding through disengagement, using proactive monitoring, technical site visits, and continuous improvement.
Manage supplier quality to ensure compliance with global regulatory standards, including GDP, GMP, and ISO requirements, as well as Amgen expectations.
Negotiate and own quality agreements.
Prepare external sites for inspections, including developing inspection playbooks.
Represent Amgen at external supplier sites during product-specific regulatory inspections and, when applicable or required, notified body audits.
Present inspection topics and demonstrate appropriate behaviors and knowledge of the subject areas.
Review and approve supplier investigations, events, and change notifications.
Approve deviations, change controls, CAPA, and CAPA effectiveness verifications.
Identify and mitigate supplier risks or escalate them to management.
Conduct Person in Plant activities as appropriate.
Drive audit commitments to completion.
Lead supplier audit preparation and identify areas of focus.
Continuously assess supplier status through periodic monitoring reports.
Partner with Operations site leads on issues, improvements, site performance, and relationship management.
Understand and implement GMP requirements internally and externally.

Benefits

Health and welfare plans for staff and eligible dependents.
Financial plans with opportunities to save for retirement or other goals.
Work/life balance and career development opportunities.
Retirement and Savings Plan with generous company contributions.
Group medical, dental, and vision coverage.
Life and disability insurance.
Flexible spending accounts.
Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models where possible.