Supervisor - Quality Assurance

Catalent Pharma Solutions•Madison, WI

3d•Onsite

About The Position

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.

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.

Nice To Haves

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

Responsibilities

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.