QA Supervisor: CAPA, Deviations & Change Control

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

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.