Manager PQA (Night Shift 12 hour) (6pm-6am)

BioSpace; New Albany (OH); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, and vision coverage

Disability insurance

Stock-based incentives

Bonus program

Job summary

Amgen’s Ohio site seeks a Manager of Quality Assurance to lead quality teams and drive a culture where quality is a mindset. You will oversee manufacturing packaging QA, deviations, CAPAs, and change controls, ensuring product quality and patient safety.

You will partner cross-functionally and lead continuous improvement initiatives, while ensuring audit readiness and regulatory compliance. This is a dynamic leadership role in a global biotech environment.

Qualifications

• Doctorate degree required; advanced degree preferred.
• Masters degree with 3+ years QA experience or a Bachelors with 5+ years QA experience.
• Multiple pathways shown: doctorate/masters/bachelors/assoc/high school with progressive QA leadership exposure.

Responsibilities

• Lead quality staff across assigned areas and shifts.
• Provide QA oversight of manufacturing packaging to ensure cGMP and regulatory compliance.
• Oversee deviations, CAPAs, change controls, validation docs and batch records.
• Drive investigations, ensure timely, thorough resolutions and inspection readiness.
• Champion continuous improvement to strengthen quality systems and operational performance.
• Collaborate with Manufacturing, QC, Engineering, Supply Chain and other functions.
• Escalate quality risks to senior leadership as needed; participate in audits and inspections.

Skills

Leadership

Quality Assurance

cGMP knowledge

Regulatory understanding

Audit readiness

Education

Doctorate degree

Masters degree

Bachelor's degree

Associates degree

High school diploma

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager PQA

What You Will Do

Lets do this. Lets 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 functionits a mindset. Were 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, its 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.

Responsibilities

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 You

We 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
• Masters degree and 3 years of quality experience
• Bachelors degree and 5 years of quality experience
• Associates degree and 10 years quality experience
• 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

• Bachelors 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 Us

As 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, well 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.

Sponsorship

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.