Automation CQV Lead

cGMP Consulting is seeking a CQV Study Director to lead cross-functional initiatives, ensure regulatory compliance, and drive change management efforts. The ideal candidate has deep experience in current Good Manufacturing Practices (cGMP), FDA regulations, and international compliance standards.

Requirements

• Define validation study scope and author protocols, risk assessments, and supporting documentation.
• Create/coordinate change control documentation.
• Ensure protocols align to specifications and risk assessments.
• Schedule validation and ancillary activities and coordinate with Engineering, QC, QA, and Validation teams.
• Oversee execution to ensure activities follow pre-approved protocols.
• Review deviations, unexpected results, and change controls affecting studies.
• Recommend protocol amendments vs. investigations through governance pathways (e.g., Validation Review Board) per procedures and best practices.
• Update risk assessments and coordinate specification updates as needed.
• Verify raw data completeness, traceability, and documentation practices.
• Ensure execution errors are corrected prior to post-approval routing.
• Author validation summary report and traceability matrix.
• Confirm acceptance criteria are met and route executed protocols/reports for approval.
• Support validation certification/closeout activities (e.g., hold tag removal) when successful.

Benefits

• Medical
• Dental
• Vision
• PTO
• 401K