Supervisor - Quality Assurance

Catalent; Madison (WI); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Paid time off

Job summary

Catalent’s Madison, Wisconsin site specializes in biologics development and manufacturing, offering state-of-the-art facilities for mammalian cell line engineering and biopharmaceutical development. We seek a Supervisor - Quality Assurance to oversee CAPA, Deviation, and Change Control, ensuring regulatory compliance and timely investigations.

The role includes leading investigations, training, and cross-functional governance, with a focus on continuous improvement and quality systems.

Qualifications

• Doctorate in a STEM discipline with a minimum of 2 years related experience, OR
• Master’s, Bachelor’s, or Associate’s Degree in a STEM discipline with a minimum of 4 years related experience, AND
• Leadership experience of 0-2 years.

Responsibilities

• Lead Deviation, CAPA, and Change Control programs for regulatory compliance and quality standards.
• Manage investigations, CAPAs, and change controls including risk assessments and effectiveness checks.
• Serve as site SME for Quality Systems and provide guidance on investigations and continuous improvement.
• Monitor quality metrics, drive process improvements, and lead governance forums.
• Support regulatory inspections and audits, fostering a culture of quality and compliance.

Skills

Leadership experience

Quality mindset

Education

Doctorate in STEM

STEM degree + 4+ years experience

Tools

Trackwise

Job description

Position Summary

• Shift: M-F 8am-5pm
• Location: Madison, WI
• 100% Onsite

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing.

Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.

We have an opportunity for a Supervisor - Quality Assurance to join our team. In this role, you will provide oversight to ensure the site Deviation, Corrective and Preventive Action (CAPA), and Change Control programs meet regulatory requirements, customer expectations, and internal quality standards. You will manage day‑to‑day activities, prioritize tasks, and ensure timely completion of investigations and actions. This position plays a key role in maintaining and improving quality systems, supporting audits, and fostering a culture of compliance and continuous improvement.

The Role

• Lead and oversee Deviation, CAPA, and Change Control programs to ensure compliance with regulatory requirements, quality standards, and customer expectations.
• Manage the full lifecycle of investigations, CAPAs, and change controls, including risk assessments, root cause analysis, impact evaluations, and effectiveness checks.
• Serve as the site Subject Matter Expert for Quality Systems, providing guidance, training, and support on compliance, investigations, and continuous improvement initiatives.
• Monitor quality metrics and trends, drive process improvements, and lead cross‑functional governance forums to ensure accountability and timely resolution of issues.
• Support regulatory inspections, customer audits, and internal audits while fostering a culture of quality, compliance, and operational excellence.

The Candidate

Minimum Requirements

• Doctorate Degree in a STEM discipline with a minimum of 2 years of related experience, OR
• Master's, Bachelor’s, or Associate’s Degree in a STEM discipline with a minimum of 4 years of related experience, AND
• Leadership experience of 0-2 years.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Preferred Skills & Background

• Knowledge in Trackwise.
• Ability to manage and support a team of three direct reports.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.