Sr. QA Specialist - Supplier Quality

Responsibilities

• Manage the overall Supplier Qualification Program to ensure compliance across all PCI facilities
• Perform supplier audits to evaluate compliance with SOPs, quality, and regulatory standards
• Create and issue audit reports and track observations to ensure timely closure
• Monitor supplier change notifications and manage non-conformance and complaint handling
• Review audit responses to ensure the non-recurrence of deficiencies
• Maintain, trend, analyze, and report quality metrics related to supplier performance
• Draft, review, and manage Quality Assurance Agreements (QAAs) and non-disclosure agreements
• Provide support during FDA and other regulatory agency inspections
• Write and revise QA Standard Operating Procedures (SOPs)

Requirements

• BS degree with 15+ years of QA GMP experience, MS degree with 10+ years, or HS diploma with 20+ years of progressive experience
• Thorough knowledge of FDA regulations (21CFR Part 210, 211 & 820), ICH, and EMEA regulations
• Proven experience with GMP quality systems in a pharmaceutical, biotech, or medical device environment
• Proficiency in MS Office, including Word, Excel, Access, and Visio
• Exceptional organizational and interpersonal communication skills

Preferred Qualifications

• Auditing certification (e.g., ASQ, CQA, or similar)
• Experience working with cross-functional teams and delivering training or presentations
• Ability to work effectively in a dynamic, fast-paced environment with minimal supervision

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We invest in people who drive progress and create a better tomorrow through operational excellence and a culture of purposeful work.