Senior Manager - Quality Assurance Operations, Client QualityPosition Summary:- Work Schedule: Monday - Friday
- 100% on-site
Catalent Madison is a pharmaceutical manufacturing site specializing in the development and production of high-quality drug products, with a strong focus on biologics and sterile injectables. The site supports global clients by delivering compliant, reliable, and scalable manufacturing solutions.
The Quality Assurance department at Catalent Madison ensures compliance with FDA regulations, other regulatory standards, and internal quality systems to support the production of high-quality drug products. It oversees critical functions such as quality systems management, manufacturing support, audits, and material disposition. Specialized groups within the department manage quality systems, manufacturing operations oversight, and compliance activities including audits, inspections, and supplier quality management.
The Role:- Leads, coaches, and develops team members to strengthen performance and support career growth
- Sets clear goals, monitors progress, provides feedback, and addresses performance issues for direct reports
- Manages QA support for cGMP manufacturing, deviations, CAPAs, validation, data review, and lot disposition
- Ensures compliant execution and continuous improvement of Quality Management Systems and related metrics
- Oversee client relationships and internal communications to maintain strong quality partnerships
- Allocates and manages QA resources to support manufacturing operations and process transfers
- Supports audits, change controls, and regulatory inspections, including CAPA development and responses
- Drives continuous improvement initiatives, cross-functional collaboration, and KPI performance enhancements
- Communicates Quality expectations and delivers site-wide GMP training
- Ensures a safe work environment while aligning team efforts with site goals, compliance standards, and business needs
- Other duties as assigned
The Candidate:- Doctorate Degree in STEM discipline with minimum of 5 years related experience, OR
- Master's Degree in STEM discipline with minimum of 8 years related experience, OR
- Bachelor's Degree in STEM discipline with minimum of 10 years related experience
- Minimum of 5 years of leadership experience
- 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.
Why you should join Catalent:- 152 hours of paid time off annually + 8 paid holidays
- Day one benefits! Medical, dental, vision and 401K benefits effective on your first day
- Potential for career growth on an expanding team
- Abundance of cross-functional exposure to other areas within the organization
