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Manager PQA

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Amgen

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Location:
United States , New Albany

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Contract Type:
Not provided

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Salary:

118235.00 - 159965.00 USD / Year

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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, coach, and develop Quality staff across assigned areas and shifts
  • Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
  • Ensure that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards
  • Review, approve, and oversee key quality systems including: Deviations
  • CAPAs
  • Change Controls
  • Validation documentation
  • Procedures and batch records
  • Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
  • Ensure production records and test results are accurate, complete, and inspection-ready
  • Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance
  • Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
  • Assess and manage quality risks, escalating critical issues to senior leadership as needed
  • Represent QA during internal and external audits and regulatory inspections
  • Support audit readiness and participate in inspection management activities
  • Ensure document control excellence, including ownership and timely periodic review of controlled documents
  • Foster a culture of quality, accountability, and compliance across all teams

Requirements:

  • Doctorate degree
  • OR Master’s degree and 3 years of quality experience
  • OR Bachelor’s degree and 5 years of quality experience
  • OR Associate’s degree and 10 years quality experience
  • OR High school diploma / GED and 12 years of quality experience
  • 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 Life Sciences, Engineering, or a related field (advanced degree a plus)
  • 3+ years of experience in Quality Assurance within a GMP-regulated environment (biotech/pharma preferred)
  • Prior leadership or people management experience strongly preferred
  • Deep knowledge of cGMP, GDP, and regulatory expectations
  • Proven experience with quality systems (deviations, CAPA, change control, validation)
  • Strong ability to lead in a shift-based operation, with flexibility for evenings, nights, weekends, or holidays
  • Excellent communication, decision-making, and problem-solving skills
  • A proactive, collaborative leader who can influence and inspire across functions
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, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans

Additional Information:

Job Posted:
April 22, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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