Senior Compliance Specialist, Supplier Quality
Position Summary:
- Work Schedule: Monday - Friday, 8:00am to 5:00pm
- 100% on-site
The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, methodservicesand analytical testing.
The Senior Compliance Specialist, Supplier Quality is responsible for leading and executing the supplier quality management program, ensuring that all external suppliers and service providers meet regulatory and company requirements. This role also supports internal and external audits, contributing to overall inspection readiness and quality system compliance.
The Role:
- Lead and manage supplier qualification, approval, and re-evaluation activities in alignment with GMP and company procedures
- Review and manage supplier complaints, supplier-related CAPAs, and change controls
- Maintain and update the Approved Supplier List (ASL)
- Collaborate with Procurement and Quality functions to ensure compliant sourcing strategies
- Assist with preparation of audit reports, tracking observations/findings, and supporting CAPA implementation
- Identify potential compliance issues and task corrective measures to prevent them, participating on assigned teams as required
- Other duties as assigned
The Candidate:
- Bachelor’s degree is required, preferably in a scientific discipline
- 5+ years of experience in GMP compliance or supplier quality in a pharmaceutical, biotechnology, or regulated industry is required
- Working knowledge of FDA, ICH, and EU GMP guidelines is required
- Must have strong organizational, communication, and analytical skills
- Experience with auditing functions and regulatory inspections is preferred
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits
- Tuition Reimbursement- Let us help you finish your degree or start a new degree!
