Senior QA Manager
Amgen
Senior Manager, Manufacturing – Manufacturing Support, Manufacturing Systems
Amgen
full-time
Posted on:
Location Type: Office
Location: Holly Springs • North Carolina • 🇺🇸 United States
Visit company websiteSalary
💰 $142,408 - $172,789 per year
Job Level
Senior
About the role
- Provide leadership and oversight for team responsible for New Product Introduction (NPI), Process Ownership (PO), Single-Use Systems (SUS), and Cleaning Validation within site manufacturing operations
- Accountable for performance, goals, and management of NPI, PO, SUS, and Cleaning Validation functions to ensure operational readiness and compliance
- Lead site activities to introduce new products and process changes, conduct facility fit assessments, manage change controls, documentation, project management, and cross-functional alignment
- Lead NPI core team meetings to drive scope, schedule, risks, and decisions; present at Tech Transfer Steering Committee (TTSC) meetings
- Oversee process ownership teams responsible for lifecycle management, continuous improvement, and compliance of core manufacturing processes including change controls, CAPAs, and SOPs
- Provide leadership for design, implementation, change management, and ongoing support of Single-Use Systems, including leak and defect management
- Direct cleaning validation programs and activities related to equipment cleaning validation (CIP/COP), sterilization (SIP/Autoclaves), and controlled temperature chambers
- Build, mentor, and develop a high-performing team with clear goals, accountability, and results
- Act as liaison with Manufacturing, Quality, Process Development, Supply Chain, Facilities & Engineering, and Finance to align priorities and execution
- Drive operational excellence, ensure regulatory compliance, and foster a culture of safety, Lean Manufacturing, and continuous improvement
Requirements
- High school diploma / GED & 12 years Quality and/or Manufacturing experience
- Associate’s degree & 10 years of Quality and/or Manufacturing experience
- Bachelor’s degree & 8 years of Quality and/or Manufacturing experience
- Master’s degree & 6 years of Quality and/or Manufacturing experience
- Doctorate degree & 2 years of Quality and/or Manufacturing experience
- Current leadership role in a GMP manufacturing facility (Preferred)
- Experience in biologics manufacturing operations for licensed commercial products (Preferred)
- Proven track record in NPI/tech transfer and project governance (Preferred)
- Depth in process validation lifecycle (process design, PPQ, CPV) (Preferred)
- Expertise in SUS management and cleaning validation programs (Preferred)
- Excellent communication and executive-level presentation skills (Preferred)
- Experience operating in matrixed, cross-site, or global networks (Preferred)
- Demonstrated application of Lean/Operational Excellence in drug substance manufacturing (Preferred)
Benefits
- Competitive benefits
- Award-winning culture described as collaborative, innovative, and science based
- Support for professional and personal growth and well-being
- Competitive and comprehensive Total Rewards Plans aligned with local industry standards
- Reasonable accommodation for individuals with disabilities during application, interview, and employment
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
New Product Introduction (NPI)Process Ownership (PO)Single-Use Systems (SUS)Cleaning ValidationChange ManagementProject ManagementProcess Validation LifecycleLean ManufacturingContinuous ImprovementCleaning Validation Programs
Soft skills
LeadershipMentoringCommunicationExecutive-level PresentationCross-functional AlignmentTeam DevelopmentAccountabilityOperational ExcellenceCollaborationProblem Solving
