Senior QAV Lead: Validation & CQV Excellence

United Pharma; New York (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma is seeking a Lead QAV Specialist to provide QA oversight for Commissioning, Qualification, and Validation activities at our GMP manufacturing facility and QC laboratories. The role focuses on ensuring cGMP compliance across validation master plans, project validation, and related qualification activities.

You will lead QA for CQV changes, manage the QAV team and CMMS collaborations, and support risk assessments and CAPAs tied to commissioning and qualification efforts.

Qualifications

• Bachelor's degree and 5+ years related experience; or Master’s with 3+ years; or PhD with up to 1 year.
• Strong knowledge of 21 CFR, ICH, EU regulations.
• Experience with Cell and Gene Therapy manufacturing is a plus.
• Experience with facility commissioning/qualification preferred.

Responsibilities

• Leads QA partnership for commissioning, qualification, and validation activities for GMP facility and QC laboratories.
• Oversees QA events related to validation and engineering operations (equipment upgrades, deviations, CAPAs).
• Authorizes CQV changes via impact assessments and QA approvals.
• Oversees CMMS by collaborating with Engineering and Lab to evaluate QA impact of requests.
• Interact with project teams to develop schedules, track milestones, and maintain timelines.
• Provide administration support for Kneat electronic validation system as needed.
• Lead QA oversight for periodic review and requalification activities.
• Manage QAV team including FTEs and contractors.
• Support Equipment Relocation program QA activities as needed.

Skills

QA oversight

cGMP knowledge

Risk assessment

Project coordination

Technical writing

Education

Bachelor's degree

Master's degree

Tools

Kneat

Veeva

Blue Mountain CMMS

Microsoft Word

Microsoft Excel

PowerPoint

Job description

United Pharma is seeking a Lead QAV Specialist to provide QA oversight for Commissioning, Qualification, and Validation activities at our GMP manufacturing facility and QC laboratories. The role focuses on ensuring cGMP compliance across validation master plans, project validation, and related qualification activities.

You will lead QA for CQV changes, manage the QAV team and CMMS collaborations, and support risk assessments and CAPAs tied to commissioning and qualification efforts.