Manager - Quality Management Systems

Overview

Manager – Quality Management Systems position in Madison, WI at Catalent Pharma Solutions.

Work schedule:

Monday–Friday 8:00AM–5:00PM, 100% on‑site.

The Quality Assurance department is responsible for ensuring compliance with FDA and other regulatory agency requirements. The role involves systems implementation and maintenance, documentation management, site‑wide training, internal and external auditing, project review, and material disposition.

• Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.
• Accountable for the Investigation and CAPA Management Systems and the Change Control Program; manage complex and high‑level deviations and support OOS investigations.
• Lead cross‑functional teams to address process and system improvement, new regulations and expectations.
• Develop, report, and monitor site‑wide metrics; present status of the Quality System at the quarterly Quality Management Review.
• Develop and provide training to support consistent and effective execution of the Quality Systems; serve as local Track Wise® subject‑matter expert.
• Maintain high‑level understanding of the Quality Management Systems and operations; provide oversight and decision making in the absence of the QA Director.

• Doctorate in a STEM discipline with a minimum of4years related experience.
• Or Master’s degree in a STEM discipline with a minimum of7years related experience.
• Or Bachelor’s degree in a STEM discipline with a minimum of9years related experience.
• Minimum 4years of leadership experience.

• 152 hours of paid time off plus 8 paid holidays.
• Generous 401(k) match.
• Medical, dental, and vision benefits effective day one.
• Tuition reimbursement.

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please email Disabili with the job number, title, and location.