QA Supervisor: Deviation, CAPA & Change Control

Catalent Pharma Solutions; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

8 holidays

Medical benefits from day one

Dental benefits from day one

Vision benefits from day one

Tuition Reimbursement

Job summary

Catalent Pharma Solutions is seeking a Supervisor - Quality Assurance in Madison, WI, onsite, to lead Deviation, CAPA and Change Control programs, ensuring regulatory compliance and robust quality systems. The role emphasizes risk assessment, root-cause analysis, and timely investigations while supporting audits and continuous improvement initiatives.

You will act as site SME, guide investigations, monitor trends, and drive cross-functional governance to maintain a culture of quality and

Qualifications

• Requires Doctorate in a STEM field with 2+ years related experience, or Master’s/Bachelor’s/Associate’s with 4+ years related experience and leadership exposure.
• Preferred TrackWise knowledge and experience.
• Ability to lead a team of three direct reports and influence cross‑functional teams.

Responsibilities

• Lead and oversee Deviation, CAPA, and Change Control programs to ensure regulatory compliance and quality standards.
• Manage investigations, CAPAs and change controls lifecycle including risk assessments and root cause analyses.
• Serve as site SME for Quality Systems and provide guidance on investigations and continuous improvement initiatives.
• Monitor quality metrics, drive process improvements, and coordinate governance forums for timely issue resolution.
• Support regulatory inspections, customer audits and internal audits to uphold compliance and quality culture.

Skills

Leadership

TrackWise

Quality systems

CAPA

Education

Doctorate in STEM

Master’s/Bachelor’s/Associate’s in STEM

Tools

TrackWise

Job description

Catalent Pharma Solutions is seeking a Supervisor - Quality Assurance in Madison, WI, onsite, to lead Deviation, CAPA and Change Control programs, ensuring regulatory compliance and robust quality systems. The role emphasizes risk assessment, root-cause analysis, and timely investigations while supporting audits and continuous improvement initiatives.

You will act as site SME, guide investigations, monitor trends, and drive cross-functional governance to maintain a culture of quality and