Head of Validation & CQV Quality

ProBio; Pennington (NJ); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending account

Health savings account

Job summary

ProBio Inc. in Pennington, NJ, seeks an Associate Director, Quality - Validation to lead CQV for GMP facilities, utilities, equipment, and processes across multiple client programs.

You will manage a team, develop IQ/OQ/PQ protocols, drive CSV, support audits and inspections, and ensure data integrity throughout the validation lifecycle. The role requires collaboration across internal groups and external vendors in a fast-paced CDMO environment.

Qualifications

• 10+ years of experience in drug/biologics GMP production environments in validation/engineering.
• Working experience in CQV for biotech/pharma facilities is required.
• Familiar with CSV according to GAMP 5 and CFR Part 11.
• Experience in validation protocol authoring for utility and equipment.
• Familiar with GMP principles and practice.
• Ability to work across functional groups for team collaboration.

Responsibilities

• Lead CQV activities for facilities, utilities, equipment, and manufacturing systems.
• Develop, review, and execute IQ/OQ/PQ protocols and validation reports.
• Support validation of facility, utility, equipment, process, cleaning, and computer systems.
• Support technology transfer and startup activities for new client programs.
• Prepare validation documentation per cGMP, FDA, EU GMP, GAMP 5, and 21 CFR Part 11.

Skills

CQV experience

CSV familiarity

Validation reports

GMP knowledge

Cross-functional collaboration

Biologics industry experience

Life science degree

Education

BS/MS in life science

Job description

ProBio Inc. in Pennington, NJ, seeks an Associate Director, Quality - Validation to lead CQV for GMP facilities, utilities, equipment, and processes across multiple client programs.

You will manage a team, develop IQ/OQ/PQ protocols, drive CSV, support audits and inspections, and ensure data integrity throughout the validation lifecycle. The role requires collaboration across internal groups and external vendors in a fast-paced CDMO environment.