Quality Systems Director – GMP & Compliance

Catalent, Inc.; 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

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.