External Supply Qa Manager

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
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