Senior Manager - Quality Assurance Operations, Client Quality

Senior Manager - Quality Assurance Operations, Client Quality

Position 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

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.

Visit Catalent Careers to explore career opportunities.

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

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.