Manager, Quality and Compliance

Catalent seeks a Manager of Quality and Compliance for its Madison biologics facility. The role oversees quality assurance functions including audits, regulatory inspections, supplier management, and process validation to ensure FDA compliance and product quality.

Responsibilities

• Manage quality assurance team supporting audits, regulatory functions, and process validation activities
• Establish training expectations and performance goals for quality assurance personnel
• Develop compliance strategies and maintain internal and client relationships
• Serve as regulatory liaison with health authorities and facilitate inspections
• Drive site improvement initiatives and monitor industry compliance trends

Requirements

• Doctorate in STEM discipline with minimum 4 years related experience, OR equivalent education and experience
• Master's degree in STEM discipline with minimum 7 years related experience, OR equivalent
• Bachelor's degree in STEM discipline with minimum 9 years related experience
• Minimum 4 years leadership experience
• Knowledge of clinical and commercial pharmaceutical programs
• Experience with regulatory inspections and quality systems