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

Initial Therapeutics, Inc.; New Albany (OH); On-site; USD 120,000 - 170,000; Full time

Job summary

Amgen in Ohio is seeking a Manager, Quality Assurance to lead quality teams, drive a culture of quality, and ensure product safety and regulatory compliance. The role oversees deviations, CAPAs, change controls, validation, and documentation, while partnering across Manufacturing, QC, and Supply Chain to deliver compliant, high-quality medicines.

The position requires advanced degrees with leadership experience in a GMP-regulated environment, and offers a comprehensive benefits package and

Qualifications

• Doctorate, Master’s, Bachelor’s, or equivalent in Life Sciences, Engineering, or related field.
• Experience directly managing people and leading teams, projects or resources.
• Understanding of GMP, GDP, and regulatory expectations.

Responsibilities

• Lead, coach, and develop Quality staff across assigned areas and shifts.
• QA oversight of manufacturing packaging to ensure compliance with cGMP, GDP, and global regulatory requirements.
• Ensure facilities, equipment, processes, materials, and products meet quality standards.
• Review, approve, and oversee Deviations, CAPAs, Change Controls, and validation documentation.
• Drive investigations and resolution of deviations with timely, compliant outcomes.
• Ensure production records and test results are inspection-ready.
• Champion continuous improvement to strengthen quality systems and operations.
• Partner cross-functionally with Manufacturing, QC, Engineering, and Supply Chain.
• Assess and manage quality risks; escalate issues to senior leadership as needed.
• Represent QA during audits and inspections; support audit readiness.

Skills

Leadership experience

Quality Assurance

cGMP knowledge

Regulatory compliance

Investigations

Education

Doctorate degree

Master's degree

Bachelor's degree

Associates degree

High school diploma

Job description

Join Amgens 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.

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. 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, 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.

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

OR

Masters degree and 3 years of quality experience

OR

Bachelors degree and 5 years of quality experience

OR

Associates 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:

• 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.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.