Manager, Auditing and Inspection Readiness
Position Summary
Work Schedule: Monday to Friday during regular business hours
100% based on-site in Greenville, NC
Catalentās 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 siteās 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.
The Role
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 followāup
Review, approve, and track audit reports, risk assessments, corrective actions, and regulatory commitments through completion
Maintain inādepth 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
The Candidate
Bachelorās 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, handsāon 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
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.
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
Why you should join Catalent
Competitive medical benefits and 401K
152 hours PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes ā
Catalent offers rewarding opportunities to further your career!Ā 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.Ā
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
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 DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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.
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