Career CategoryQuality
Job DescriptionManager PQAWhat you will doLet's do this. Let's change the world. At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a function-it's a mindset. We're seeking a
Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety.
This is more than a role, it's an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide.
Lead Quality. Inspire Excellence. Impact Patients.As a QA Manager, you will lead and elevate quality performance while providing strategic and operational oversight across manufacturing and quality systems. Key responsibilities include:
- 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
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.
Basic Qualifications: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
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:- 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 you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comSalary Range118,235.00USD -159,965.00 USD
