Senior Compliance Specialist, Supplier Quality
Catalent Pharma Solutions
Position Overview Senior Compliance Specialist, Supplier Quality – 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 supports internal and external audits, contributing to overall inspection readiness and quality system compliance. Key Responsibilities 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 implement corrective measures to prevent them. Participate on assigned teams as required and perform other duties as assigned. Candidate Qualifications Bachelor’s degree in a scientific discipline (preferred). 5+ years of experience in GMP compliance or supplier quality in the pharmaceutical, biotechnology, or regulated industry. Working knowledge of FDA, ICH, and EU GMP guidelines. Strong organizational, communication, and analytical skills. Experience with auditing functions and regulatory inspections (preferred). Benefits & Offers 152 hours of PTO + 8 paid holidays. Generous 401K match. Medical, dental, and vision benefits. Tuition reimbursement options. Equal Opportunity Statement Catalent is an Equal Opportunity Employer, including disability and veterans. #J-18808-Ljbffr Catalent Pharma Solutions
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