Associate Director, Quality - Validation

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company-mâ

Paid parental leave after 3 months

Paid time off (vacation/personal/sick/

Flexible spending accounts

Health savings accounts

Life and AD&D insurance

Commuter benefits

Job summary

ProBio Inc. in Pennington, New Jersey is seeking an Associate Director of Quality - Validation to lead CQV across GMP facilities, utilities, equipment, and computer systems.

You will drive validation strategies, mentor a team, and ensure cGMP/FDA CFR Part 11 compliance, with global collaboration to support multiple client programs. You will oversee IQ/OQ/PQ development, risk-based decisions, and continuous improvement while partnering with internal departments and external vendors to safeguard

Qualifications

• BS/MS in life science with 10+ years in GMP production.
• CQV experience for biotechnology/pharmaceutical facilities.
• Familiar with CSV per GAMP 5 and CFR Part 11.
• Experience writing validation protocols for utilities and equipment.
• Strong ability to collaborate across functional groups.

Responsibilities

• Lead a team to execute CQV for facilities, utilities, equipment, and systems.
• Develop, review, and execute IQ, OQ, PQ protocols and validation reports.
• Support validation activities for facility, utilities, equipment, processes and CSV.
• Coordinate validation with manufacturing, QA, QC, IT, and vendors.
• Maintain validation docs and ensure data integrity throughout lifecycle.
• Support client audits, regulatory inspections, and internal quality audits.

Skills

CQV experience

Cross-functional collaboration

FDA CFR Part 11 knowledge

GAMP 5 familiarity

Education

BS/MS in life science

Tools

IQ/OQ/PQ protocol writing

Validation documentation management

Job description

Associate Director, Quality - Validation

Pennington, New Jersey, United States

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

About the Job:

The position reports to the Sr. Director, Quality Assurance and is responsible for leading a team of validation personnel to perform commissioning, qualification, and validation (CQV) activities for GMP manufacturing facilities, utilities, equipment, computerized systems, and manufacturing processes. This position plays a key role in supporting multiple client programs across clinical and commercial manufacturing within a fast-paced CDMO environment.

This person will lead the ongoing commissioning and qualification of the GMP Gene Therapy Areas, GMP Plasmid Manufacturing Area, the Quality Control (QC) laboratories, Microbiology, Raw Material, Sample and Stability areas. This includes facilities, utilities, systems, equipment, computerized systems, and instrument qualification/validation activities.

This person will work cross-functionally with internal departments (Analytical Development, Manufacturing, IT, EHS, etc.) and external resources (Vendors, Consultants, Contract Laboratories, etc.), both domestically and internationally, to support manufacturing and laboratory related issues. Theywill be accountable for realization of the site validation master plan, and to develop and maintain the re-qualification and equipment lifecycle program using quality risk management principles. This person manages direct reports and has the ability to develop, grow, direct and motivate a team in a fast-paced environment. The incumbent will be required to strategize long-term, maintain & execute a validation quality plan, and drive continuous improvement.

Responsibilities:

• Lead a team to execute commissioning, qualification, and validation (CQV) activities for facilities, utilities, process equipment, and manufacturing systems.
• Lead a team to develop, review, and execute IQ, OQ, PQ protocols and validation reports.
• Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities.
• Support technology transfer and startup activities for new client manufacturing programs.
• Prepare and lead a team responsible for 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 a team to participate 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 for continuous improvement of validation processes and engineering systems.
• Support multiple client projects simultaneously while ensuring project timelines and quality requirements are achieved.

Qualifications:

• BS/MS in life science or related field with 10+ years of experience in drug/biologics industry in GMP production environment in roles of validation/engineering.
• Working experience in CQV for biotechnology/pharmaceutical facility is required.
• Familiar with CSV in accordance to GAMP 5 and CFR Part 11.
• Familiarity with process, cleaning, assay validation a plus.
• Experience in authoring of validation protocols for utility and equipment required.
• Familiar with GMP operational principles and practice.
• Ability to work across functional groups for team collaboration.

Pay range is estimated between $130k - $170k based on skill set and experience.

#AH

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

ProBio Inc. maintains a drug-free workplace.