Associate Director, CQV

Position Overview

The Associate Director of Commissioning, Qualification, and Validation (CQV) is responsible for leading and executing CQV activities for a large-scale biologics manufacturing facility in compliance with regulatory requirements, including 21 CFR Parts 11, 210, and 211, as well as ASTM E2500 guidelines. This role ensures that all facility, utility, equipment, and process qualification activities are conducted efficiently and in alignment with Good Engineering Practices (GEP) and Risk-based Validation approach. This role exists to guarantee the integrity and compliance of production systems and to mitigate risks associated with the therapeutic product lifecycle. The Associate Director,CQVcollaborates with cross-functional teams to drive continuous improvement and optimize CQV practices.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

Job Description

What You'll Do

 

• Acts as CQV Technical Lead for the entire site to establish validation strategies, develop validation procedures to align with FDB Large Scale Biologics platform operating principles and regulatory requirements.• Ensures compliance with 21 CFR Parts 11, 210, and 211, ASTM E2500, ISPE Baseline Guides, and industry best practices. • Provide leadership for the risk-based verification approach, ensuring CQV programs focus on critical aspects affecting product quality and patient safety. • Collaborates with Quality, Engineering, Manufacturing, and Regulatory teams to ensure alignment on validation strategies and readiness for regulatory inspections. • Participates and represents CQV in new client or new molecule business proposal reviews and assists with onboarding of new molecules at the site level. • Leads presentations of FDBN’s Validation Lifecycle program during internal and external audits• Chairs the various steering committees such as process change board, change control board, PQ (Performance Qualification) council etc. • Establishes Validation standard operating procedures (SOPs), Validation Project Plan (VPP), Validation Master Plan (VMP) to ensure full cGMP compliance by operations launch.• Provides guidance and leads the management of validation lifecycle using the ASTM E2500 principles, for the entire site for all equipment, facilities, utilities, during Installation Verification (IV)/Operational Verification (OV)/Installation & Operational Qualification (IOQ)/ Performance Qualification (PQ) through Good Manufacturing Practices (GMP) release to decommissioning• Manages validation lifecycle activities, including URS development, design qualification (DQ), risk assessments, FAT/SAT, and periodic requalification. • Ensures the integration of process validation (PV), cleaning validation (CV), and computerized system validation (CSV) into the overall CQV strategy. • Develops the strategy for periodic reviews and requalification of equipment, utilities, facilities to ensure cGMP compliance• Oversees deviation investigations, change control evaluations, and continuous improvements within the validation framework, ensuring on-time closure and completion of compliance initiatives• Provides CQV leadership for capital projects, ensuring timely execution of validation activities within budget and schedule constraints. • Provides technical support and leads team of external validation engineers through commissioning, qualification and validation of large-scale biologics facilities and equipment.• Manages CQV