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.
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
Master's degree and 6 years of Quality or Operations experience
Bachelor's degree and 8 years of Quality or Operations experience
Associate's degree and 10 years of Quality or Operations experience
High school diploma / GED and 12 years of Quality or Operations experience
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
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.