Amgen Senior Manager Quality Assurance - Supplier Quality in West Greenwich, Rhode Island

Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. Alignment with CTA / Marketing Application.

Responsibilities

  • 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 XPD etc.

  • 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.

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

  • Review / Approve Master Batch Records

  • Quality approver for deviations, change controls, CAPA

  • Prepare inspection playbooks

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

  • Perform Person in Plant activities as required

  • APR Data Provider

  • Manage Audit commitments to completion

  • Decision to release or Reject batches (Dynamic is different for SREs), approve or reject deviations, Change Control, CAPA, and approve QAGR

  • Provide Quality position on GMP related topics and strategy for the site

  • Decision to approve Master batch Records/Raw Material Specifications

Basic Qualifications :

  • Doctorate degree and 2 years of Quality or Operations experience

  • OR

  • Master's degree and 6 years of Quality or Operations experience

  • OR

  • Bachelor's degree and 8 years of Quality or Operations experience

  • OR

  • Associate's degree and 10 years of Quality or Operations experience

  • OR

  • High school diploma / GED and 12 years of Quality or Operations experience

  • AND

  • 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications :

  • 10 + years biotech or pharmaceutical industry experience

  • Bilingual

  • 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.