Senior Manager, Quality Systems

Catalent • Greendale, IN

1d • Onsite

About The Position

The Senior Manager, Quality Systems leads the Quality and Compliance functions at Catalent’s Greendale, Indiana site, a gummy development and manufacturing center serving the Wellness business. The role oversees Quality Assurance Supervisors and Specialists responsible for operational quality, sampling, testing, and product release, ensuring compliance with applicable industry standards and regulations while driving continuous improvement. The position collaborates with cross-functional teams to protect product integrity and ensure consistent delivery of high-quality dietary supplement products.

The role oversees quality and compliance for dietary supplement manufacturing, including quality documentation and change controls, food safety programs, facility sanitation, investigations, audits, training, performance measurement, and regulatory communications. It works closely with Operations, Customer Service, Product Development, Technical Operations, Supply Chain, site management, regulatory agencies, auditors, and other stakeholders.

The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. The role is 100% onsite in Greendale, Indiana. The position requires regular sitting, standing, and walking, occasional lifting up to 15 pounds, access to manufacturing and office areas, and use of office equipment and a computer monitor.

Requirements

• Bachelor’s degree in science or a related field, such as Chemistry, Microbiology, or Biology.
• At least five years of pharmaceutical and dietary supplement quality experience.
• At least seven years of related experience, including three to four years in a supervisory or management role.
• Experience with current Good Manufacturing Practice compliance and a quality role in pharmaceutical or dietary supplement manufacturing.
• Ability to work effectively under pressure to meet deadlines.
• Ability to sit, stand, and walk regularly and occasionally lift up to 15 pounds; lifting more than 44.09 pounds requires assistance.
• Ability to access manufacturing-floor and office staff areas and use required office equipment; specific vision requirements include reading written documents and frequent computer-monitor use.

Nice To Haves

• Demonstrable leadership experience at Catalent, including participation in Catalent-sponsored programs such as NGGL, GOLD, LEAD Now, GM Excellence, or GROW, may be considered in place of external experience.
• Experience writing investigations, including root cause analyses and reports for annual product reviews.
• Familiarity with 21 CFR 111, 21 CFR 117, 21 CFR 211, GFSI, HACCP, Preventive Controls Qualified Individual, SQF, NSF, and UL certifications.
• Experience with electronic systems such as JDE, TrackWise, Electronic Document Management System, Learning Management System, Quality Management System, Veeva, Compliance Wire, and Stability Programs.
• Experience communicating with FDA inspectors or other regulatory agents and handling FDA 483 responses.
• Experience using artificial intelligence tools to improve quality systems.

Responsibilities

• Oversee Quality and Compliance functions related to dietary supplement manufacturing at the Greendale site.
• Lead Quality Assurance Supervisors and Specialists responsible for operational quality, product sampling, testing, and product release.
• Review and approve manufacturing and packaging change controls, product formulations, label changes, deviations, corrective and preventive action plans, and customer complaints.
• Ensure compliance with FDA, NSF, and SQF requirements and participate in internal and external audits.
• Develop and maintain quality and compliance policies, procedures, and guidelines.
• Identify and mitigate product-quality risks and oversee root cause analyses and corrective actions.
• Lead the Food Safety Team and ensure compliance with 21 CFR 110 and 117, HACCP Food Safety, and Food Defense Plans.
• Monitor the sanitary condition of the facility and equipment to support cross-contamination control.
• Work with Operations to assess sanitation program effectiveness and compliance with food safety guidelines.
• Maintain communication with Customer Service to address quality issues affecting product release.
• Oversee training programs on quality standards and compliance requirements.
• Establish and track key performance indicators for quality and compliance performance.
• Collaborate with Product Development, Technical Operations, and Supply Chain to integrate quality into production processes.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
• Communicate with regulatory agencies, external auditors, and internal stakeholders on quality and compliance matters.
• Oversee investigations, environmental monitoring, and critical control point incidents that affect product release.
• Support site management in enforcing current Good Manufacturing Practices and mentor staff in compliance.
• Facilitate internal assessments, compliance meetings, and training sessions.

Benefits

• Competitive paid time off and eight paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement to support completing or earning a degree.
• Site-based employee engagement activities.
• Employee Resource Groups focused on diversity and inclusion.
• Environmentally friendly community engagement and green initiatives.
• Defined career path and annual performance review process with potential for career growth.
• WellHub program promoting physical and mental wellness.
• Perkspot discounts from more than 900 merchants.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior