Manager, Quality and Compliance

Catalent; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Catalent in Madison, WI is seeking a Manager, Quality and Compliance to oversee Quality Assurance resources and ensure compliance with regulatory expectations. The role involves developing strategies for QA functions, serving as a liaison with health authorities, and leading a team for performance improvement.

The ideal candidate has a STEM doctorate with at least 4 years of experience or a master's with 7 years, including leadership skills. Join us to contribute to innovative biologic treatments.

Qualifications

• Minimum of 4 years related experience with Doctorate Degree.
• Minimum of 7 years related experience with Master's Degree.
• Minimum of 9 years related experience with Bachelor's Degree.

Responsibilities

• Manage Quality Assurance resources for audits and regulatory functions.
• Establish training expectations for QA personnel.
• Develop strategies to facilitate compliance and foster relationships.
• Serve as regulatory liaison with health authorities.
• Lead a team to improve performance and support development.

Skills

Quality Assurance Management

Regulatory Liaison

Training and Development

Compliance Strategies

Team Leadership

Education

Doctorate Degree in STEM discipline

Master's Degree in STEM discipline

Bachelor's Degree in STEM discipline

Job description

Position Summary

• Work Schedule: M-F 8am-5pm
• 100% on-site

Catalent Biologics is a fast‑growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state‑of‑the‑art biomanufacturing facility in Madison, WI, and our market‑leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world‑class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

Role: Manager, Quality and Compliance

• Manages the Quality Assurance resources assigned to supporting internal and customer audits, regulatory support functions, customer quality agreements, supplier quality management, and process validation activities (i.e., PPQ, CPV, APR).
• Establishes functional and overall training expectations for Quality Assurance personnel engaged in the Quality & Compliance functions.
• Understands the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
• Develops and implements strategies to facilitate compliance and foster internal and client relationships; applies advanced theoretical knowledge and contributes to the development of new principles and concepts.
• Serves as regulatory liaison with applicable Health Authorities, as assigned, and facilitates regulatory inspections.
• Recommend and supports site improvement initiatives and drives inspection readiness.
• Functions as a strong liaison to customers and other functional departments, providing meaningful quality and regulatory support and ensuring productive cross‑functional communication.
• Monitors and communicates industry compliance trends and regulatory expectations.
• Leads team members to improve and reinforce performance of others.
• Take responsibility for direct reports’ performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance‑related concerns and issues promptly.
• Works with coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee’s career development.
• Other duties as assigned

The Candidate

• Doctorate Degree in STEM discipline with minimum of 4 years related experience
• Master's Degree in STEM discipline with minimum of 7 years related experience
• Bachelor's Degree in STEM discipline with minimum of 9 years related experience, Leadership experience minimum of 4 years

Catalent is an Equal Opportunity Employer, including disability and veterans.