Manager, Quality and Compliance

Catalent

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

Apply

Vacancy posted 28 days ago

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