Manager - Quality Assurance, Operations

Catalent Pharma Solutions•Madison, WI

17d•Onsite

About The Position

The Manager for QA Operations oversees team activities supporting manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping. The manager leads and develops team members, ensures compliance with CGMP and Quality Management System requirements across manufacturing and quality control operations, and supports site performance targets. The role serves as a primary Quality interface with clients and oversees change control, audit readiness, audit responses, and corrective and preventive actions. The manager also champions continuous improvement and communicates Quality expectations across the site while maintaining a safe, compliant work environment. The position is based on-site at Catalent’s Madison, Wisconsin facility, a GMP biologics development and manufacturing site with mammalian cell line engineering, biomanufacturing, formulation, and analytical capabilities. The work schedule is Monday through Friday, with core hours from 8 a.m. to 5 p.m.

Requirements

Bachelor’s degree in a STEM discipline and at least 9 years of relevant GMP experience in QA Operations, including at least 4 years in a leadership capacity; alternatively, a Master’s degree with 7 or more years of relevant experience, or a PhD with 4 or more years of relevant experience.
Ability to ensure data integrity and compliance with company SOPs, specifications, cGMP, ICH, FDA, and EMA requirements.
Ability to integrate and interpret data across multiple disciplines and command the full biologics process.
Ability to communicate complex technical information to non-technical audiences and lead challenging discussions with customers and team members to resolve issues effectively.
Experience in most aspects of drug development and life-cycle support, with the ability to develop strategies and tactics to meet regulatory milestones.
Must be able to see, hear, read, and write clear English and comply with EHS responsibilities.
Physical capability for frequent sitting, standing, walking, reading written documents, using a computer monitor, reaching, talking, writing, and listening; occasional stooping, kneeling, crouching, bending, carrying, and grasping; frequent lifting or moving up to 10 pounds and occasional lifting or moving up to 50 pounds.

Nice To Haves

Demonstrable leadership experience at Catalent, including participation in programs such as NGGL, GOLD, LEAD Now, GM Excellence, or GROW, may be considered in place of external experience.

Responsibilities

Lead, coach, and develop team members by setting goals, monitoring performance, providing feedback, and addressing performance concerns.
Build employee capability through targeted training, mentorship, and career-development planning.
Ensure compliant execution of CGMP and QMS requirements across manufacturing and quality control operations; track metrics and drive process improvements.
Serve as a primary Quality interface with clients, managing communications and maintaining quality relationships aligned with client expectations.
Ensure Quality resources are available to support GMP operations, technology transfers, batch execution, and site performance targets.
Oversee change control, audit readiness, audit responses, and the development and implementation of CAPAs.
Recruit, develop, and lead a high-performing Quality team in alignment with department and site strategic objectives.
Champion continuous improvement, communicate Quality expectations across the site, lead cross-functional efforts, and deliver periodic GMP and focused training.
Maintain a safe, compliant work environment.
Perform other duties as assigned.