Senior QA Manager – External Supply Quality, Supplier Quality Management

This is a fully remote position, open to applicants in California, +3 more states.

📋 Description

• Act as the quality lead and subject matter expert for key global suppliers of GMP raw materials.

• Manage the complete quality oversight of designated suppliers—from onboarding through ongoing performance monitoring to disengagement.

• Serve as the primary quality liaison for internal stakeholders, facilitating issue resolution, supplier strategy, and cross-functional initiatives.

• Conduct proactive quality management of suppliers to ensure adherence to global regulatory standards.

• Review and authorize quality documentation.

• Participate in and/or lead supplier audits while collaborating with both internal and external partners.

• Prepare Amgen sites and suppliers for audits and inspections.

• Identify and mitigate risks related to suppliers or escalate them to management as necessary.

• Ensure the completion of audit commitments.

• Act as a key quality collaborator with External Supply, Manufacturing, Supply Chain, Material Sciences, Engineering Technical Authority (ETA), Process Development, and other internal functions.

• Lead and/or engage in cross-functional initiatives and continuous improvement projects.

⛳️ Requirements

• High school diploma / GED with 12 years of Quality experience OR Associate’s degree with 10 years of Quality experience OR Bachelor’s degree with 8 years of Quality experience OR Master’s degree with 6 years of Quality experience OR Doctorate degree with 2 years of Quality experience.

• A minimum of 2 years of experience in directly managing people and/or leadership experience in leading teams, projects, programs, or directing resource allocation.

• Educational background in Life Sciences.

• Strong technical knowledge and experience in operations within the pharmaceutical or GMP-regulated industry.

• Relevant work experience in Drug Substance and Drug Product operations, ideally with single-use systems and platforms.

• Over 5 years of experience overseeing supplier quality.

• Proven experience in robust problem-solving and root-cause analysis.

• Strong continuous improvement mindset.

• Comprehensive knowledge of compliance, quality, and regulatory standards, with critical thinking skills and an inquisitive, end-to-end perspective.

• Excellent report writing and presentation abilities.

• Experience driving decision-making using DAI principles.

• Familiarity with industry requirements and expectations of a Quality Management System (QMS).

• Proficient with data and Artificial Intelligence tools.

• Understanding of applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• 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 feasible.