External Supply QA Manager (manual)

Amgen; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Amgen is seeking a Quality professional to lead oversight of drug product and finish drug product CMOs, ensuring GMP compliance across manufacturing, testing and release.

You will represent Amgen in deviations, change controls, CAPAs and batch dispositions, review master batch records, and prepare for regulatory inspections. This role requires cGMP experience and strong cross-functional collaboration in a global biotech environment.

Qualifications

• Experience leading QA reviews of batch records, deviations and CAPAs.
• Proven ability to coordinate with CMOs and regulatory bodies.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead representation, communication and management of quality issues with internal and external partners.
• Serve as main Quality contact for deviations, change controls, CAPAs, and batch disposition.
• Provide quality oversight of manufacturing, testing, and release at CMOs.
• Review Master Batch Records and related cGMP documentation.
• Prepare for regulatory inspections and support inspections at contract sites.
• Identify risk, drive quality improvements and escalate as needed.

Skills

Quality oversight

Regulatory inspections

CAPA management

Deviation & change control

Batch record review

Cross-functional collaboration

Negotiation

Leadership of cross-functional teams

Project management

Education

Master’s degree in Science

Bachelor’s degree in Science

Associate’s degree

High school diploma / GED

cGMP Experience

Job description

Quality

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Description

Quality and Compliance Oversight of Drug Product and Finish Drug Product CMOs

• Specific Purpose Contract
• Remote
• Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain, etc.
• Lead the representation, communication and management of quality issues with internal partners and external partners
• Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition etc. related to Amgen product.
• 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.
• QA review of all documentation associated with batch release to ensure GMP compliance.
• Negotiator, author and Approver of 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, as applicable or required.
• Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers as required. Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
• Review / Approve Master Batch Records
• Prepare inspection playbooks
• Identify and mitigate Risk at the CMO or testing Laboratories and/or escape to management
• Perform Person in Plant activities as required
• 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.

Authority

• Decision to release or reject batches
• Decision to approve or reject an External site change implementation / deviation
• Advise on External site status
• Advise on External site Inspection readiness
• Identify opportunities and issues, then determine when escalation is necessary
• 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
• 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.