Amgen Inc. is hiring an External Supply QA Manager to be the primary Quality point of contact and approver for Amgen products at Contract Manufacturing Organizations (CMOs) and Contract Laboratories. You will manage quality oversight, compliance, and batch disposition for external manufacturing partners while leading quality representation during regulatory inspections.

What You'll Do

Be an integral quality member of Amgen cross-functional contract manufacturing team.
Lead the representation, communication and management of quality issues with internal and external partners.
Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition.
Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements.
Review completed production batch records as necessary and approve master batch records, and other cGMP documents from CMOs / Contract Laboratories.
Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs.
Conduct QA review of all documentation associated with batch release to ensure GMP compliance.
Negotiate, author and approve quality agreements.
Lead the preparation of the site for and represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site.
Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers.
Review and approve Master Batch Records.
Prepare inspection playbooks.
Identify and mitigate risk at the CMO or testing Laboratories and/or escalate to management.
Perform Person in Plant activities as required.
Act as an APR Data Provider.
Provide Amgen Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement.
Monitor and communicate site performances in means of quality metrics to Amgen and Contract Manufacturer.
Identify prioritization opportunities and determine when escalation is necessary.
Develop strong partnership/relationship with CMO / testing Lab.
Manage submission related activities at CMOs as it pertains to international launches, global expansion etc.

What We're Looking For

Doctorate degree OR
Master’s degree & 2 years of directly related experience OR
Bachelor’s degree & 4 years of directly related experience OR
Associate’s degree & 10 years of directly related experience OR
High school diploma / GED & 12 years of directly related experience

Nice to Have

4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
cGMP Experience
Ability to oversee multiple projects simultaneously
Able to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to negotiate a position after taking feedback from multiple sources
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
Ability to manage diverse relationships
Ability to lead and manage cross-functional teams
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/External sites