CQV Lead, Compliance

Warren - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description:

The role will focus on commissioning qualification and validation (CQV) oversight while ensuring compliance with regulatory standards and internal quality systems.
This position requires strong leadership attention to detail and familiarity with computerized maintenance/asset management systems-specifically Maximo as the site is currently migrating processes into Maximo.

Responsibilities:

Lead CQV compliance activities ensuring adherence to FDA cGMP and internal quality standards.
Provide oversight of commissioning qualification and validation deliverables across equipment utilities and facilities.
Review and approve protocols summary reports deviations and change controls.
Collaborate with cross-functional teams (Engineering QA Manufacturing IT) to drive compliance initiatives.
Support audits and inspections by preparing documentation and responding to regulatory queries.
Manage and track compliance-related activities using Maximo during system migration and steady-state operations.
Train and mentor junior team members on CQV compliance requirements and best practices.

Requirements:

Bachelors degree in engineering Life Sciences or a related field.
7 years of experience in commissioning qualification and validation within the pharmaceutical/biotech industry.
Strong knowledge of cGMP FDA and ICH guidelines.
Experience with Maximo (preferred; strong plus if involved in system migrations).
Excellent technical writing documentation and communication.

Job Description: The role will focus on commissioning qualification and validation (CQV) oversight while ensuring compliance with regulatory standards and internal quality systems. This position requires strong leadership attention to detail and familiarity with computerized maintenance/asset manag...