Sr. Specialist, Compliance QA

Role: Senior Compliance QA Specialist supporting quality and compliance systems at the Raleigh site. Responsibilities include authoring Annual Product Reviews (APRs), conducting self-inspections, managing Change Control and CAPA records, and drafting Quality Agreements. The role involves ensuring inspection readiness, regulatory compliance, facilitating audits, reviewing GMP documentation, and tracking compliance metrics. Requirements: Bachelor's in life sciences, engineering, or related field; minimum 5 years GMP/GXP pharmaceutical experience; expertise in GMP regulations, authoring APRs, conducting internal audits (Certified Quality Auditor preferred), and technical writing skills. High-Value: 5+ years GMP experience in pharmaceutical manufacturing; experience with Quality Systems, audits, CAPA, and GxP compliance; familiarity with lab data review, Veeva, and regulatory trends. Collaboration: Interacts extensively with site personnel, internal audit teams, and regulatory auditors. WorkSetup: On-site with less than 10% travel.