Principal Quality Associate, Supplier Audits

Principal Quality Associate, Supplier Audits Role

About Site

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs. Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.

Position Summary

We have an opportunity for a Principal Quality Associate, Supplier Audits, to join our team. This role involves performing and facilitating system-based audits and risk assessments for Supplier Audits and Internal Quality Systems. You will support both non-commercial and commercial audits as well as the Inspection Readiness Program. The position requires strong organizational skills to manage audit schedules, ensure compliance, and maintain quality standards across the organization.

Shift: Monday- Friday, 8:00am-5:00pm
Location: Grenville, NC
100% Onsite

The Role

• Conduct supplier audits, including desktop and internal site audits, to ensure compliance with quality and regulatory requirements.

• Use TrackWise for audit management, quality events, and documentation tracking.

• Perform supplier risk assessments and manage supplier qualification questionnaires.

• Review quality documentation to verify compliance with Good Manufacturing Practices and customer requirements.

• Manage audit schedules and coordinate audit activities with internal teams and suppliers.

• Ensure confidentiality agreements are in place before audit execution.

• Collaborate with Site Subject Matter Experts to prepare for and support supplier audits.

• Manage TrackWise audit records and ensure timely responses to client observations and audit findings.

• Monitor site quality metrics, identify trends, and track audit observations to support continuous improvement.

• Support regulatory inspections by preparing documentation and coordinating responses to regulatory agencies.

• Maintain strong client relationships by managing supplier observations, corrective actions, and ensuring timely communication and resolution of audit findings.

• Other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor’s degree in a technical field with at least 6 years of professional experience in the pharmaceutical industry, including 3 years in a Quality Auditing function.

• Associate degree in a technical field with at least 7 years of professional experience in the pharmaceutical industry, including 4 years in a Quality Auditing function.

• In lieu of a technical degree, at least 8 years of professional experience in the pharmaceutical industry, including 5 years in a Quality Auditing function, and completion of formal auditing training may be substituted.

• At least 5 years of experience in a direct Quality role required.

• Demonstrated knowledge of regulations and guidelines associated with current Good Manufacturing Practices for the pharmaceutical industry.

• Knowledge of manufacturing and/or laboratory processes required.

Preferred Skills & Background

• ASQ Certified Quality Auditor or equivalent certification preferred.

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 8 paid holidays.

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

• Tuition Reimbursement – support to finish your degree or earn a new one.

• Site-based Employee Engagement activities such as Music Bingo, Puppy Supply Donation Program, Halloween Costume Contests, and more.

• Employee Resource Groups focusing on Diversity and Inclusion.

• Environmentally friendly, community engagement green initiatives including regular participation in Highway Clean-up.

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