Amgen · 4 hours ago
Senior Specialist, Quality Assurance
United States
Full-time
Remote
Mid, Senior Level
4+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Senior Specialist in Quality Assurance will play a key role in supporting Global Supplier Quality and ensuring successful regulatory outcomes through inspection readiness and quality management system assessments.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Own and lead the SQM/GSQ inspection readiness processes, ensuring best-in-class inspection execution and outcomes across global and virtual sites
Provide strategic and tactical leadership for inspection and audit preparation, inspection and audit room execution (front room/ back room), fielding questions, managing change, and guiding teams through inspection and audit activities
Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites, partnering closely with established site leads and subject matter experts
Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates to ensure strong audit/inspection preparedness and alignment to regulatory expectations and industry trends
Maintain and continuously improve inspection readiness processes, including strategy sessions, pressure tests, and readiness tools; represent GSQ in audits, inspections, and global networks
Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and Amgen Global Quality Compliance internal audits
Drive proactive identification, communication, and resolution of site and cross-functional compliance risks across the global network
Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation, testing, training, and post-implementation support for >300 staff
Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation. (e.g., DQMS for A&I in 2026)
Qualification
Required
Doctorate degree & 2 years of Quality Compliance experience OR
Master's degree & 4 years of Quality Compliance experience OR
Bachelor's degree & 6 years of Quality Compliance experience OR
Associate's degree & 10 years of Quality Compliance experience OR
High school diploma / GED & 12 years of Quality Compliance experience
Risk-based decision making
Cross-functional collaboration & leadership
Technical writing
Problem solving
Continuous improvement
Project / Program management
Preferred
Bachelor's degree in Life Sciences or Engineering
Experience leading or participating in key roles for Regulatory/Health Authority inspections, including preparation, execution, and response phases
Experience auditing and defending processes/procedures during inspections
7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management
Strong understanding of EU and US cGMP, exposure to GDPs, and knowledge of supplier/partner quality challenges
Demonstrated ability to work autonomously, communicate effectively, present data clearly, and navigate ambiguity with structured problem-solving
Experience leading cross-functional teams and driving continuous improvement initiatives
Ability to maintain strong remote working relationships across global teams
Ability to travel regionally and internationally as needed
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 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
Recent News
2026-01-24
2026-01-22
Company data provided by crunchbase