Manager - Quality Management Systems

Catalent • Madison, WI

1d • Onsite

About The Position

Manager - Quality Management Systems
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.
Catalent Pharma Solutions in Madison, WI is hiring an 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.
The Role:
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.
Mains 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 TrackWise® 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

Requirements

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

Responsibilities

• 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 TrackWise® 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

Benefits

• 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 start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees