QA Sr Manager

The QA Sr Manager role is responsible for Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. This position is responsible for being an integral quality member of Amgen cross-functional Supplier Quality team that includes but is not limited to business operations, analytical science, process development, supply chain.

Responsibilities Include:

Execute Amgen Supplier audits

Negotiator and Approver of quality agreements

Lead the preparation of the site for and represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.

Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas

Quality approver for deviations, change controls, CAPA

Prepare inspection playbooks

Identify and mitigate Risk at the Supplier, CMO and/or testing Laboratories and/or escalate to management

Manage Audit commitments to completion

Basic Qualifications:

Doctorate degree & 2 years of Quality or Manufacturing or Operations experience

OR

Master's degree & 6 years of Quality or Manufacturing or Operations experience

OR

Bachelor's degree & 8 years of Quality or Manufacturing or Operations experience

OR

Associate's degree & 10 years of Quality or Manufacturing or Operations experience

OR

High school diploma / GED & 12 years of Quality or Manufacturing or Operations experience

Preferred Qualifications:

10 + years biotech or pharmaceutical industry experience

Auditor Certification or experience performing audits

Raw Material Compendial Testing proficiency

Knowledge of Single Use Systems, Resins, and filters in an aseptic manufacturing facility

Additional European Languages

Significant Quality experience at Aseptic Manufacturing facilities

Able to facilitate and influence senior stakeholders and partners

Able to successfully manage workload and timelines

Familiarity with basic project management tools

Ability to negotiate a strategic position after taking feedback from multiple sources

Strong project management, problem-solving, and analytical skills

Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results

Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution

Ability to operate in a matrixed or team environment with site, functional, and executive leadership

Experience driving decision making by using DAI principles

Experience with the "variation management" process

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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, or disability status.