External Supply QA Manager

Description

Quality and Compliance Oversight CMOs and alignment with CTA / Marketing Application.

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 escalate 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