Manager - Quality Management Systems

Manager
- Quality Management Systems

• 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.

Catalent Pharma Solutions in Madison, WI is hiring a Manager
- Quality Management Systems. The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site‑wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition.

Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

The Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training.

• 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.
• Responsible for managing complex and high‑level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems.
• Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification and implementation of improvement opportunities for established Quality Systems processes, procedures, and training to support Deviation, Out‑of‑Specification, CAPA and Change Control processes.
• Responsible for reporting and monitoring site wide metrics internally and to corporate on pre‑defined basis.
• Responsible for presenting the status of the Quality System at the quarterly Quality Management Review.
• Develops and provides training to support consistent and effective execution of the Quality Systems.
• Serves as local Track Wise® Subject Matter Expert.
• Drives alignment and improvement initiatives, leading cross function teams, to address process
  improvement, system improvement, and new regulations/expectations.
• Responsible for maintaining high level understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Director.
• Provides technical assistance and training for personnel.
• Other duties as assigned.

• 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.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Positive working environment focusing on continually improving processes to remain innovative.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• 152 hours of PTO + 8 paid holidays.
• Generous 401K match.
• Medical, dental and vision benefits effective day one of employment.
• Tuition Reimbursement – Let us help you finish your degree or…