CQV Lead

Job Title: CQV Lead, Compliance
Location: Warren, NJ (50% Onsite)
Long Term Contract

Role Overview:
We are seeking an experienced CQV Lead, Compliance to support compliance and validation activities at the BMS site in Warren, NJ. 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.

Key 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.

Qualifications:

• Bachelor's 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 skills.
• Proven ability to work in a fast-paced, matrixed environment.

Work Arrangement:

• Hybrid role 50% onsite in Warren, NJ (remaining remote)