Senior Manager Quality Assurance: Incoming Quality and Warehouse

Senior Manager QA What You Will Do

At Amgen, our mission to serve patients drives everything we do. In this role you will lead quality assurance across product and process in a dynamic environment, shaping a culture where quality is a mindset and ensuring our therapies are safe and effective worldwide.

• Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on‑floor support, record review, quality oversight of deviation investigations and changes, and document approval.
• Ensure AOH product is manufactured, tested, stored and distributed according to cGMP, Amgen standards and applicable regulations.
• Drive investigations and resolution of deviations, ensuring timely, thorough and compliant outcomes.
• Lead and participate in Quality Risk Assessments.
• Provide quality input to support project or operational design decisions.
• Build organization according to hiring strategy that supports growth. Partner with HR to recruit, coach, develop, motivate and retain staff, ensuring the structure adapts to evolving business needs.
• Oversee implementation and maintenance of the Amgen Quality Management System in accordance with corporate standards.
• Track performance and drive continuous improvement in quality outputs aligned with quality strategies.
• Develop strategies to support regulatory inspections and site audits.
• Serve as quality representative to regulatory authorities, Amgen Corporate auditors and third parties.
• Manage area budget, expense and identify productivity improvement opportunities.
• Represent AOH quality in cross‑function and cross‑site forums.
• Alert management of significant quality, compliance, supply and safety risks.
• Communicate across all levels of the organization and facilitate the development of solutions to critical business issues.

Doctorate degree and 2 years of quality/ manufacturing/ engineering experience

OR
Master’s degree and 6 years of quality/ manufacturing/ engineering experience

OR
Bachelor’s degree and 8 years of quality/ manufacturing/ engineering experience

OR
Associate’s degree and 10 years of quality/ manufacturing/ engineering experience

OR
High school diploma / GED and 12 years of quality/ manufacturing/ engineering experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leading teams, projects, programmes or directing the allocation of resources.

• Master or Bachelor’s Degree in a Life Science field
• 5+ years pharmaceutical industry experience
• Previous experience in quality oversight
• Strong knowledge of cGMPs and experience interacting with regulators
• Proven experience with quality systems (deviations, CAPA, change control, validation)
• Ability to drive process improvement within area of responsibility
• Ability to manage workload to timelines, decision‑making and problem‑solving skills
• Leadership and communication skills. A proactive, collaborative leader who can influence and inspire across functions.

• 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.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where possible.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on skills, experience and qualifications.

Sponsorship for this role is not guaranteed.

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 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. Please contact us to request accommodation.