Manager - Quality Management Systems

About the role

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.

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.
• Reports and monitors 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.

Qualifications

• 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.

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

Pay

152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits effective day one of employment

Schedule

100% on-site
M-F 8am-5pm