Senior Specialist, Quality Assurance

Amgen • Thousand Oaks, CA

3d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Specialist Quality Assurance What you will do Let’s do this. Let’s change the world. In this vital role, you will serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Supplier Quality Management (SQM) activities, with primary responsibility for Inspection Readiness and QMS Assessment & Improvement (A&I) programs. You will drive quality excellence across Amgen’s global external network and play a central role in ensuring successful regulatory outcomes.

Requirements

• 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 & 10years 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

Nice To Haves

• 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

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).

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees