Amgen · 23 hours ago
Senior Manager Quality Assurance – Incoming Quality Raw Materials /Disposition
Holly Springs, NC
Full-time
Hybrid
Senior Level
6+ years expAmgen is a biotechnology company focused on serving patients living with serious illnesses. In this role, you will lead a team of Quality professionals to oversee Disposition and Incoming Quality operations, ensuring compliance with quality systems and regulatory requirements.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations)
Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements
Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring
Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations
Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays
Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact
Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program
Represent the Quality unit during internal and external audits and regulatory inspections
Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed
Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline
Qualification
Required
High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR
Associate's degree and 10 years of Quality and Manufacturing support industry experience OR
Bachelor's degree and 8 years of Quality and Manufacturing support industry experience OR
Master's degree and 6 years of Quality and Manufacturing support industry experience OR
Doctorate degree and 2 years of Quality and Manufacturing support industry experience
Preferred
Educational background in Life Science and/or Engineering
Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems
In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice
Hands-on experience with Disposition, Incoming, and Quality Systems—particularly investigations, corrective actions, and audit readiness
Experience managing and interacting with regulatory and internal auditors
Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills
Effective risk management, negotiation, and cross-functional collaboration abilities
Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
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