Senior Director Quality Assurance

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In this leadership role, you will oversee quality oversight of GMP manufacturing processes at Amgen Rhode Island (ARI) through the advancement of Amgen’s pipeline and diversified portfolio from our state‑of‑the‑art Drug Substance manufacturing site located in West Greenwich. You will drive operational work streams, provide quality leadership and guidance to site partners, and integrate technology to ensure effective and efficient tech transfer, maintaining compliant ongoing operations.

• Lead the Plant QA team and provide quality oversight of a 24/7 continuous manufacturing operation, supporting 14 products and accelerated run rate and expansion projects.
• Provide on‑floor support for multiple facilities and areas including AR5 Fed batch, AR30 MoF, I‑530, Buffer Preparation, Media Preparation, Component Preparation, and In‑Process Testing.
• Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices, Amgen standards, and applicable regulations.
• Maintain the Amgen Quality Management System in accordance with corporate standards.
• Track performance and drive continuous improvement in quality outputs aligned with quality strategies.
• Partner with cross‑site and cross‑functional leads to advance Amgen’s manufacturing strategy.
• Prepare for regulatory inspections and site audits, representing quality to regulatory authorities and auditors.
• Develop and manage the area budget, identify productivity improvement opportunities, and alert management of significant risks.
• Communicate across all levels of the organization and facilitate development of solutions to critical business issues.

• Doctorate degree and 4 years of quality/manufacturing/engineering experience.
• Masters degree and 8 years of quality/manufacturing/engineering experience.
• Bachelor’s degree and 10 years of quality/manufacturing/engineering experience.
• At least 5 years of experience directly managing people or leading teams, projects, or programs.

• Bachelor’s degree in a Life Science field.
• 15+ years of pharmaceutical industry experience.
• Experience in quality oversight of biologics drug substance operations.
• Strong knowledge of cGMPs and experience interacting with regulators.
• Track record of driving process improvement and managing workload to timelines.
• Leadership and communication skills.

Expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $ – $. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.

• 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.
• Discretionary annual bonus program and stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where possible.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Final date to receive applications:
None. We will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship for this role is not guaranteed.