Senior Manager, Quality Systems

Catalent; Lawrenceburg (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive PTO

Medical, dental, vision benefits

Tuition Reimbursement

Site engagement activities

Job summary

Catalent, Inc. in Greendale, IN is seeking a Senior Manager of Quality Systems to lead the Quality and Compliance functions onsite.

You will supervise QA Supervisors and Specialists, ensuring operational quality, testing, and product release meet stringent regulatory standards. You will collaborate with cross-functional teams to maintain product integrity, drive continuous improvement, and ensure timely supplier and customer satisfaction while maintaining rigorous FDA, NSF, and SQF compliance

Qualifications

• Bachelor’s degree in science or related field with 5+ years in pharmaceutical/dietary supplement quality.
• 7+ years of related experience, including 3–4 years in supervision.
• GMP compliance experience in pharma/dietary supplement.
• Ability to work under pressure; sit/stand; lift up to 15 pounds.
• Catalent leadership program experience may count in place of external experience.

Responsibilities

• Oversee Quality and Compliance functions for dietary supplement manufacturing.
• Lead QA Supervisors and Specialists for release and testing.
• Review change controls, formulations, label changes, deviations, CAPA, and complaints.
• Ensure FDA, NSF, SQF compliance and participate in audits.
• Develop and maintain quality policies, procedures, and guidelines.
• Drive continuous improvement in quality and efficiency.

Skills

Quality leadership

Regulatory compliance

GMP experience

Audit readiness

Cross-functional collaboration

Root cause analysis

Education

Bachelor’s degree in science

Tools

JDE

TrackWise

Quality Management System

Veeva

Compliance Wire

Stability Programs

LMS

Job description

About Site

Catalent’s Greendale, Indiana site is a key part of the company’s Wellness business, serving as one of North America’s primary gummy development and manufacturing centers. The site specializes in the formulation and production of traditional gelatin gummies and 100% plant-based pectin gummies for nutritional supplements and nutraceutical applications, supporting a wide range of consumer health products. With strong in-house R&D, quality laboratories, and flexible manufacturing and packaging capabilities, the Greendale operation partners closely with customers to develop innovative, high-quality, and consumer-friendly gummy delivery formats across a variety of flavors, shapes, and functional ingredients, all produced under rigorous quality and food-safety standards.

Position Summary

We have an opportunity for a Senior Manager, Quality Systems to join our team and lead the Quality and Compliance functions at the Catalent Greendale site. This role oversees a team of Quality Assurance Supervisors and Specialists responsible for operational quality, product sampling, testing, and release. The position ensures compliance with industry standards and regulations while driving continuous improvement across the Quality organization. The successful candidate will collaborate with cross‑functional teams to maintain product integrity and ensure the consistent delivery of high‑quality products to our customers.

Shift: Monday through Friday, 8:00AM - 5:00PM

Location: Greendale, IN

100% Onsite

The Role

• Oversee Quality and Compliance functions related to dietary supplement manufacturing at the Catalent Greendale site.


• Lead a team of 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 for product manufacturing and participate in internal and external audits.


• Develop and maintain quality and compliance policies, procedures, and guidelines.


• Identify and mitigate risks related to product quality 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 state of the facility and equipment to ensure cross-contamination control.


• Collaborate with Operations to assess the effectiveness of sanitation programs and ensure compliance with food safety guidelines.


• Maintain a feedback loop with Customer Service to address quality issues affecting product release.


• Oversee training programs to educate staff on quality standards and compliance requirements.


• Establish and track key performance indicators to measure quality and compliance performance.


• Collaborate with Product Development, Technical Operations, and Supply Chain teams to integrate quality into all production processes.


• Drive continuous improvement initiatives to enhance product quality and operational efficiency.


• Communicate effectively with regulatory agencies, external auditors, and internal stakeholders on quality and compliance matters.


• Oversee investigations, environmental monitoring, and critical control point incidents impacting product release.


• Support site management in enforcing current Good Manufacturing Practices and mentoring staff in compliance.


• Facilitate internal assessments, compliance meetings, and training sessions.

The Candidate

Minimum Requirements

• Bachelor’s degree in science or related field (Chemistry, Microbiology, or Biology) and at least five years of pharmaceutical and dietary supplement quality experience.


• Minimum of seven years of related experience, including three to four years in a supervisory or management role.


• Experience in current Good Manufacturing Practice compliance and working in a quality role within the pharmaceutical or dietary supplement manufacturing industry.


• Ability to work effectively under pressure to meet deadlines. The individual may be required to sit, stand, walk regularly, and occasionally lift up to 15 pounds; no lifting greater than 44.09 pounds without assistance. Must be accessible to the manufacturing floor and office staff and use required office equipment. Specific vision requirements include reading written documents and frequent use of a computer monitor.


• 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.

Preferred Skills & Background

• Experience with investigation writing, including root cause analysis and report preparation for annual product reviews.


• Familiarity with regulations 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.

Why You Should Join Catalent

• Positive and fast‑paced working environment focusing on continually improving processes to remain innovative and dynamic.


• Competitive Paid Time Off plus eight paid holidays.


• Medical, dental, and vision benefits effective day one of employment.


• Tuition Reimbursement - support to complete or earn a new degree.


• Site-based Employee Engagement activities such as End-of-Summer and NFL kickoff celebrations, March Madness tournament, Summer Food Truck Fridays, Veterans Appreciation Lunch, Homemade Chili Cook-off, Salsa Competition, Ice Cream Sundae Bar, and more.


• Employee Resource Groups focusing on Diversity and Inclusion.


• Environmentally friendly, community engagement green initiatives.


• Defined career path and annual performance review process with potential for career growth on an expanding team.


• WellHub program promoting overall physical and mental wellness.


• Perkspot offering exclusive discounts from over 900 merchants across various categories.

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.