External Supply QA Manager

Amgen; Ireland; Remote; EUR 90,000 - 150,000; Full time

Benefits offered by this job

Base salary

Total Rewards Plans aligned with local

Job summary

Amgen is seeking a Quality professional to oversee Drug Product CMOs and ensure GMP compliance across manufacturing, testing, and release processes. You will act as the primary quality contact for deviations, CAPAs, and batch disposition, managing CMOs to contractual quality agreements and regulatory requirements.

You will lead inspections readiness, coordinate with internal teams, and drive risk management across Amgen sites and contract partners, enabling successful regulatory outcomes and

Qualifications

• Doctorate or equivalent with related experience.
• Associate degree +10 years or high school diploma +12 years related experience.
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry.

Responsibilities

• 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 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.
• Lead inspection preparations and represent Amgen at regulatory inspections when required.
• Identify risk at the CMO/testing labs and elevate to management.
• Monitor quality metrics and communicate site performances to Amgen and Contract Manufacturer.

Skills

Quality management

Cross-functional leadership

Leadership

Project coordination

Education

Doctorate degree

Master’s degree & 2 years of related experience

Bachelor’s degree & 4 years of related experience

Associate’s degree & 10 years of related experience

High school diploma / GED & 12 years of related experience

Job description

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

Key Responsibilities

• 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 elevate 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

Basic Qualifications

• 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

Preferred Qualifications

• 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

What You Can Expect Of Us

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.

• Base salary
• 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.