Associate Director, Quality - Validation

ProBio•Pennington, NJ

9h•$130,000 - $170,000

About The Position

ProBio, a subsidiary of GenScript, is a global CDMO providing services from discovery through GMP for plasmids, antibodies, and cell and gene therapies. The Associate Director, Quality - Validation reports to the Sr. Director, Quality Assurance and leads validation personnel responsible for commissioning, qualification, and validation (CQV) across GMP manufacturing facilities and laboratories. The role supports multiple client programs across clinical and commercial manufacturing in a fast-paced CDMO environment. The position leads ongoing CQV for GMP gene therapy and plasmid manufacturing areas, QC laboratories, microbiology, raw material, sample, and stability areas. Scope includes facilities, utilities, systems, equipment, computerized systems, and instruments. The role collaborates with internal departments and external resources, oversees delivery of the site validation master plan, and develops and maintains requalification and equipment lifecycle programs using quality risk management principles. It also manages and develops a team, executes a validation quality plan, and drives continuous improvement.

Requirements

BS or MS in life science or a related field.
10+ years of experience in the drug or biologics industry in a GMP production environment, in validation or engineering roles.
Working experience in CQV for a biotechnology or pharmaceutical facility.
Familiarity with computerized system validation in accordance with GAMP 5 and 21 CFR Part 11.
Experience authoring validation protocols for utilities and equipment.
Familiarity with GMP operational principles and practices.
Ability to collaborate across functional groups.

Nice To Haves

Familiarity with process validation, cleaning validation, and assay validation.

Responsibilities

Lead a team executing commissioning, qualification, and validation activities for facilities, utilities, process equipment, and manufacturing systems.
Lead the development, review, and execution of IQ, OQ, and PQ protocols and validation reports.
Support facility, utility, equipment, process, cleaning, and computer system validation activities.
Support technology transfer and startup activities for new client manufacturing programs.
Prepare and oversee validation documentation in accordance with cGMP, FDA, EU GMP, GAMP 5, and 21 CFR Part 11 requirements.
Support deviation investigations, CAPAs, change controls, and risk assessments related to validation activities.
Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external vendors.
Lead team participation in FAT, SAT, commissioning, equipment qualification, and facility expansion projects.
Maintain validation documentation and ensure data integrity throughout the validation lifecycle.
Support client audits, regulatory inspections, and internal quality audits.
Identify opportunities to improve validation processes and engineering systems.
Support multiple client projects simultaneously while meeting project timelines and quality requirements.
Realize the site validation master plan and develop and maintain requalification and equipment lifecycle programs using quality risk management principles.
Manage, develop, direct, and motivate a team, and maintain and execute a validation quality plan.

Benefits

Medical, dental, and vision insurance.
401(k) retirement plan with company match that vests fully on day one.
Paid parental leave after three months of employment.
Paid time off including vacation, personal time, sick time, floating holidays, and company holidays.
Flexible spending and health savings accounts.
Life and AD&D insurance.
Short- and long-term disability coverage.
Legal assistance.
Supplemental pet, critical illness, accident, and hospital indemnity insurance plans.
Commuter benefits.
Well-being initiatives.
Peer-to-peer recognition programs.