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Senior Director Quality Assurance

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Amgen

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Location:
United States , West Greenwich

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Category:
-

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Contract Type:
Not provided

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Salary:

218358.00 - 252850.00 USD / Year
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Job Description:

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Job Responsibility:

  • Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities
  • Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition
  • Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications
  • Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
  • Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
  • Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy
  • Develop strategies in support of regulatory inspections and site audits
  • Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
  • Develop area budget, manage expenditure and identify productivity improvement opportunities
  • Represent ARI Quality in cross-function and cross-site forums
  • Provide Quality input to support project or operational design decisions
  • Alert management of significant quality, compliance, supply, and safety risks
  • Communicate across all levels of the organization
  • Facilitate development of solutions to critical business issues

Requirements:

  • Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
  • Master’s degree and 8 years of Quality/Manufacturing/Engineering experience
  • Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
  • At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Nice to have:

  • Bachelor’s Degree in a Life Science field
  • 15 + years’ pharmaceutical industry experience
  • Previous experience in Quality oversight of Biologics drug substance operations
  • Strong knowledge of cGMPs and experience interacting with Regulators
  • Able to drive process improvement within area of responsibility
  • Able to successfully manage workload to timelines
  • Leadership and communication skills
What we offer:
  • 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

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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