Senior Consultant, Quality Compliance & Data Integrity

We are seeking experienced Senior Consultants to support a pharmaceutical client in Greenville, NC, with a primary focus on retrospective Data Integrity review, Sterility Assurance, and GMP Quality within sterile products' manufacturing.

Key Responsibilities

• Conduct comprehensive retrospective review of GMP documentation and historical data processes, and associated validation/qualification records.
• Assess records and data against ALCOA+, FDA cGMP, and Data Integrity requirements .
• Identify potential data integrity, GMP, and compliance gaps and assess their potential impact on product quality, GMP compliance, and sterility assurance .
• Review relevant batch records, deviations, CAPAs, environmental monitoring, microbiology, validation/qualification, and computerized system records.
• Support investigations, root cause analysis, impact assessments, and remediation activities related to the FDA 483 observations.
• Clearly document findings, rationale, and recommendations in an inspection-ready format .
• Demonstrated experience supporting Sterility Assurance and GMP Quality activities within

Required Experience

• 6+ years of pharmaceutical/GMP experience , preferably in sterile manufacturing.
• Strong expertise in Data Integrity, GMP Quality Compliance, and Sterility Assurance .
• Proven experience with retrospective data reviews and FDA remediation .
• Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA .
• Previous experience supporting an FDA inspection, Form 483 response, or remediation .