Associate Director, Quality - Validation

About the role

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.

They will 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 and benefits

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

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Benefits

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. maintains a drug-free workplace.
• Please note: ProBio Inc. will only contact candidates through verified application sources. Probio does not request personal information from candidates through individual email or any other platform.