Manager, Quality Auditing and Inspection Readiness

Catalent

1d•Onsite

About The Position

Manager, Auditing and Inspection Readiness Position Summary Work Schedule: Monday to Friday during regular business hours 100% based on-site in Greenville, NC Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Manager, Auditing and Inspection Readiness is accountable for maintaining continuous inspection readiness across the site. The role owns and oversees the site’s auditing and inspection readiness programs and provides leadership to Quality Assurance professionals and Subject Matter Experts in support of regulatory inspections, client audits, internal audits, and supplier evaluations. The Manager, Auditing and Inspection Readiness ensures ongoing compliance with global regulatory requirements, drives continuous improvement initiatives, and fosters a strong culture of quality, integrity, and inspection readiness throughout the organization.

Requirements

Bachelor’s degree with 10+ years of progressive experience in the pharmaceutical industry OR
Associate degree with 12+ years of progressive experience in the pharmaceutical industry required
Prior people leadership, including direct supervision, coaching and performance management of a team preferred
Demonstrated Quality Assurance auditing experience within a regulated GMP pharmaceutical environment
Must have extensive, hands‑on experience leading both internal and external audits in a regulated GMP pharmaceutical environment, including regulatory inspections (e.g., FDA, Health Canada, EMA) and client audits
Ability to sit, stand, and walk for extended periods of time
Ability to work in an office and manufacturing environment, including periodic time spent in production and laboratory areas
Ability to use standard office equipment such as a computer, telephone, and copier
Ability to occasionally lift or move materials up to approximately 25 pounds
Ability to travel as required to support audits, inspections, and vendor evaluations

Nice To Haves

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.

Responsibilities

Own and maintain the site Inspection Readiness Program to ensure sustained compliance with applicable global regulatory requirements
Plan and manage preparedness activities for client audits and regulatory inspections, supporting successful outcomes
Plan, schedule and lead internal audits and supplier evaluations, ensuring effective execution and follow‑up
Review, approve, and track audit reports, risk assessments, corrective actions, and regulatory commitments through completion
Maintain in‑depth knowledge of applicable regulations (including CFR, EudraLex, PMDA, ICH, TGA, and Health Canada) and ensure appropriate interpretation and application at the site and with suppliers
Monitor regulatory changes, perform gap assessments, define action plans, and drive sustainable compliance improvements
Manage site licensing and provides regulatory documentation and responses to clients and regulatory authorities as required.
Manage the record retention rooms (including off site storage), archival of records and issuance of site logbooks / notebooks
Identify and lead continuous improvement and lean initiatives to enhance audit effectiveness, efficiency, and client experience
Other duties assigned