Automation CQV Lead

cGMP Consulting•North Chicago, IL

About The Position

cGMP Consulting is seeking a CQV Study Director to serve as the single point of control and accountability for qualification/validation studies. In this role, you will own validation activities from scope definition through execution oversight and final approval, ensuring regulatory compliance, data integrity (ALCOA+), and cross-functional alignment. The ideal candidate will have a proven ability to lead cross-functional initiatives, navigate complex troubleshooting challenges, drive change management efforts, and ensure timely and thorough completion of protocols. This candidate has deep experience in current Good Manufacturing Practices (cGMP), along with a solid understanding of FDA regulations, and international compliance standards.

Requirements

Minimum Bachelors’ degree in Engineering, Science, or a related field of study.
5+ years’ experience in a GMP manufacturing environment, including drafting standard operating procedures, protocols, and/or reports. Must be familiar with regulatory (FDA) requirements.
Strong knowledge of validation lifecycle practices, deviation/investigation workflows, change control fundamentals, and data integrity principles.
Advanced critical thinking and technical writing skills.
Strong organizational, communication, and interpersonal skills.

Responsibilities

Define validation study scope and author protocols, risk assessments, and supporting documentation.
Create/coordinate change control documentation.
Route documents for review/approval and drive timely turnaround.
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.
Ensure executors are properly trained (or supervised), signature logs are complete, and technical reviews are performed.
Confirm test methods are suitable, acceptance criteria are defined, and documentation is complete.
Review deviations, unexpected results, and change controls affecting studies.
Determine impact to validation status and lead validation investigations.
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.