Senior Manager, Quality Systems

Catalent Pharma Solutions LLC; Greendale (IN); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition Reimbursement

Competitive Paid Time Off

Holiday pay

Career development programs

Job summary

Catalent’s Greendale, Indiana site is seeking a Senior Manager, Quality Systems to lead Quality and Compliance, overseeing QA Supervisors and Specialists in product sampling, testing, and release. The role ensures FDA/NSF/SQF compliance and drives continuous improvement across the Quality organization.

The successful candidate will collaborate with cross-functional teams to maintain product integrity and ensure high-quality nutraceutical manufacturing.

Qualifications

• Bachelor’s degree in science (Chemistry, Microbiology, or Biology) and at least five years of pharmaceutical/dietary supplement quality experience.
• Minimum of seven years of related experience, including 3–4 years in a supervisory/management role.
• Experience in current Good Manufacturing Practice (GMP) compliance within pharma or dietary supplement manufacturing.
• Ability to work effectively under pressure to meet deadlines.

Responsibilities

• 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, CAPAs, and customer complaints.
• Ensure compliance with FDA, NSF, SQF requirements and participate in internal/external audits.
• Develop and maintain quality and compliance policies, procedures, and guidelines.

Skills

Leadership

Regulatory knowledge

Quality systems management

Root cause analysis

Audits

Education

Bachelor's degree in science (Chemistry, Microbiology, or Biology)

Tools

JDE

TrackWise

Electronic Document Management System

Learning Management System

Quality Management System

Veeva

Compliance Wire

Stability Programs

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

• 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.

Equal Opportunity and Accommodation

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 [e-mail].

Agency and Search Firm Notice

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 [e-mail] for us to investigate with local authorities.

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

Volunteer Work Disclosure

Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.