Sr. Specialist, Quality Systems

About Gen Script

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

About Pro Bio:

Pro Bio, 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. Pro Bio 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:

Contributes to the administration, maintenance, and continuous improvement of Pro Bio’s Quality Management System (QMS) to ensure compliance with applicable GMP regulations, industry standards, and company procedures for both clinical and commercial Cell and Gene Therapy products. This role supports quality system processes including deviations, lab investigations, Corrective and Preventative Actions (CAPA), change controls, complaints, risk management, training, document control, management review, and regulatory inspection readiness.

The position collaborates cross-functionally with internal teams, customers, and external resources (when required) to ensure compliance and drive a culture of quality and operational excellence.

Responsibilities:

Quality Management System (QMS)

• Maintain and continuously improve Pro Bio Inc. and external Quality Management Systems ensuring GxP compliance with worldwide manufacturing regulations, guidelines, and current regulatory requirements for both clinical and commercial Cell and Gene Therapy products manufactured and/or tested at the Hopewell, NJ facility.
• Manage and perform Quality Assurance (QA) review and approval of documentation related to Change Control, Corrective and Preventative Action (CAPA), Deviations, Laboratory Investigations, incidents, complaints, exceptions, and Out of Specification (OOS) reports as generated by Pro Bio Hopewell, NJ facility in accordance with current QA procedures.
• Facilitate and support Pro Bio internal team members with Root Cause Analysis and Investigations using established methodologies. Drives completion of Investigations and ensures timely implementation and effectiveness verification of CAPAs as needed.
• Monitor quality system performance and overdue actions.
• Support development, implementation, and monitoring of quality metrics and Key Performance Indicators (KPIs).
• Analyze quality trends and generate quality management review reports. Recommend and implement process improvements to enhance effectiveness and compliance.

Inspection and Audit Support

• Participate in customer audits, regulatory inspections, and internal audits.
• Coordinate responses to audit observations and inspection findings.
• Maintain inspection readiness at all times.

Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelor’s degree in a scientific discipline with 3+ years of experience in QA or related role(s) in a pharmaceutical, biotechnology or related environment.
• Demonstrated experience with GxP document management systems and/or other QMS (e.g. Veeva Quality Docs,…