Senior Quality Assurance Manager

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

📋 Description

• Oversee quality management of primary component suppliers.

• Serve as the quality lead throughout the supplier relationship lifecycle, from onboarding to disengagement.

• Evaluate supplier performance through proactive monitoring, technical site visits, and ongoing improvement initiatives.

• Ensure suppliers adhere to global regulatory standards, including GDP, GMP, and ISO.

• Negotiate and maintain quality agreements.

• Prepare external facilities for inspections, including the creation of inspection playbooks.

• Represent Amgen at supplier locations during regulatory inspections and notified body audits.

• Present inspection topics and demonstrate expertise in relevant subject areas.

• Review and approve supplier investigations, events, and change notifications.

• Authorize deviations, change controls, CAPA, and CAPA EVs.

• Identify potential supplier risks and escalate them to management as needed.

• Perform Person in Plant duties as required.

• Ensure audit commitments are completed efficiently.

• Lead preparations for supplier audits and identify key focus areas.

• Evaluate supplier status through regular monitoring reports.

• Collaborate with Operations site leaders on issues, improvements, site performance, and relationship management.

• Implement GMP requirements both internally and externally.

⛳️ Requirements

• Doctorate degree with 2 years of Quality experience OR Master’s degree with 4 years of Quality experience OR Bachelor’s degree with 6 years of Quality experience OR Associate’s degree with 10 years of Quality experience OR high school diploma/GED with 12 years of Quality experience.

• Over 10 years of experience in the biotech or pharmaceutical industry.

• At least 5 years of experience in overseeing supplier quality.

• Proven experience in leading audits.

• Technical expertise related to primary components.

• Familiarity with Quality Processes and systems such as Trackwise and Veeva.

• Demonstrated experience in quality oversight of primary components.

• History of presenting during inspections and audits.

• Ability to facilitate and influence senior stakeholders and partners.

• Strong prioritization skills to manage workload and meet deadlines.

• Proficient in negotiating strategic positions after gathering feedback from various sources.

• Excellent project management, problem-solving, and analytical skills.

• Proven ability to lead cross-functional teams and deliver timely, high-quality results.

• Strong collaboration and communication skills to balance divergent inputs and drive issue resolution.

• Capability to operate effectively in a matrixed or team environment with site, functional, and executive leadership.

• Experience in managing relationships with external parties.

• Proficient with data and Artificial Intelligence tools.

• Willingness to travel domestically and internationally up to 20%.

🏝️ Benefits

• Retirement and Savings Plan with generous company contributions.

• Comprehensive group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work models where feasible.

• Career development opportunities.

• Work/life balance benefits.

• Health and welfare plans for staff and eligible dependents.

• Financial plans allowing opportunities to save for retirement or other goals.