Quality Assurance Senior Manager
| Company | Amgen |
|---|---|
| Location | Los Angeles, CA, USA |
| Salary | $141158 – $164599 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD, Associate’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Doctorate degree and 2 years of quality and compliance experience
- Master’s degree and 4 years of quality and compliance experience
- Bachelor’s degree and 6 years of quality and compliance experience
- Associate’s degree and 10 years of quality and compliance experience
- High school diploma / GED and 12 years of quality and compliance experience
Responsibilities
- Be an integral quality partner of Amgen’s cross-functional external supply team that includes: business operations, analytical sciences, process development, and supply chain.
- Perform general oversight and periodic evaluations of Quality performance for contract manufacturing/testing sites.
- Negotiate Quality Agreements (QAGR) and ensure adherence to QAGR terms.
- Review and approve master batch records, test methods, deviations, change controls, CAPAs, CAPAEV’s, and Product Complaints.
- Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site.
- Provide data for Annual Product Review (APR).
- Support audits/inspections (e.g. prepare topics to be presented during inspections). Support management of audit/inspection commitments to completion.
- Represent Amgen at product-specific regulatory inspections and/or during notified body audits of the contract manufacturing site.
- Ensure inspection readiness (e.g. prepare playbooks, participate in mock inspections).
- Identify and mitigate risks at supplier site and raise to management as appropriate.
- Perform tactical batch disposition activities in support of lot release.
- Role may require occasional travel.
Preferred Qualifications
- Bachelor’s of Science degree
- 8+ years biotech or pharmaceutical industry experience.
- Significant Quality and/or Manufacturing experience at small and/or large molecule DS, DP or FDP manufacturing facilities. Experience with synthetics/small molecules a plus.
- Ability to facilitate and influence senior partners and balance workload and timelines.
- Ability to negotiate a strategic position after taking feedback from multiple sources.
- Strong project management (PM), problem-solving, and analytical skills and familiarity with PM tools.
- Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing).
- Shown ability to lead cross-functional teams, consistently deliver timely and quality results.
- A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issue to resolution.
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
- Skilled in using risk based decision-making approaches
- Experience with the regulatory activities and ‘variation management’