Manager - Quality Assurance, Operations

Manager - Quality Assurance (QA), Operations

Position Summary:

Work Schedule: Monday Friday, core hours 8am-5pm

100% on-site (Madison, WI)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Manager for QA Operations has oversight of the team activities involving manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping. You will be a key member in the growth and development within your department.

The Role:

• Lead, coach, and develop team members by setting clear goals, monitoring performance, delivering feedback, and addressing performance concerns promptly
• Build and support employee capability through targeted training, mentorship, and career?development planning
• Ensure compliant execution of all CGMP and Quality Management System (QMS) requirements across manufacturing and quality control operations, including tracking metrics and driving process improvements
• Serve as a primary Quality interface with clients, managing communication, sustaining strong quality relationships, and ensuring alignment with client expectations
• Ensure adequate Quality resources are available to support GMP operations, including technology transfers, batch execution, and achievement of site performance targets
• Oversee change control processes, audit readiness, and audit responses, including the development and implementation of corrective and preventive actions (CAPAs)
• Recruit, develop, and lead a high?performing Quality team, aligning personnel development and motivation with department and site strategic objectives
• Champion continuous improvement initiatives and communicate Quality expectations across the site, including leading cross?functional efforts and delivering periodic GMP and focused trainings while maintaining a safe, compliant work environment
• Other duties as assigned

The Candidate:

• Bachelor's degree minimum is required in a STEM discipline plus a minimum of 9 years of relevant GMP experience in QA Operations with at least 4 years in a leadership capacity
• We will also accept a Master's degree with 7+ years OR a PhD with 4+ years of relevant experience
• Must be able to ensure data integrity and full compliance with company SOPs, specifications, cGMP, ICH, FDA, and EMA requirements, while integrating and interpreting data across multiple disciplines while commanding the full Biologics process
• Demonstrated ability to communicate complex technical information to non?technical audiences and lead challenging discussions with customers and team members to drive issues to effective resolution
• Must be experienced in most aspects of drug development and life cycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
• Physical requirements: Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 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
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Personal initiative. Dynamic pace. Meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.