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Auditing and Compliance Expert
2 months ago
Job Summary:
Catalent Inc is seeking a highly skilled and experienced Regional Quality Assurance Lead to join our team. As a key member of our Global Supplier Quality Management team, you will be responsible for leading and managing the Supplier Auditor Team, performing audits, and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Oversight and leadership of the regional Supplier Auditor Team, ensuring timely completion of audits and generation of audit reports.
- Support to Supplier Quality site teams on routine queries and guidance, ensuring seamless communication and collaboration.
- Management of Supplier notification mailbox, ensuring active management and delegation within the supplier team and associated Quality Compliance Assessments.
- Development of metrics to provide visibility of audits due, planned audit dates, audits complete, audit reports process timelines, and overdue audits.
- Collation and communication of common finding categories to identify risk areas across the supplier base.
- Proactive planning to ensure maintenance of audits assigned to the Supplier auditor team, mitigating overdues.
- Collaboration with cross-functional business relationships within Global functional groups, such as Procurement, Sites, and Supply Chain, to ensure risks are identified, mitigated, and communicated.
- 40% travel expectations annually (domestic & international).
Requirements:
- Bachelor's Degree, required; Certified auditor or lead auditor credentials, preferred.
- Five years+ auditing experience and supervisory experience, required.
- Experience working in an auditing role within the Pharmaceutical/Medical Device industry.
- Knowledge and understanding of EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices.
- Working knowledge of industry-related guidelines such as ICH Q7, GHTF, and IPEC.
- Demonstrable leadership experience at Catalent Inc (including but not limited to participation in Catalent-sponsored leadership programs) may be considered in place of external experience.
Why Catalent Inc:
- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- 152 hours of PTO + 8 paid holidays.
- Several Employee Resource Groups focusing on D&I.
- Dynamic, fast-paced work environment.
- Positive working environment focusing on continually improving processes to remain innovative.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Community engagement and green initiatives.
- Generous 401K match.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement.
- WellHub - program to promote overall physical wellness.
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
