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 resource allocation, including internal teams and external CQV contractors. • Drives continuous improvement initiatives to optimize CQV processes and reduce validation cycle times. • Ensures proper documentation control and approval processes for all validation deliverables. • Coaches and mentors’ direct reports and team members to foster professional development and growth• Participates in the recruitment process to attract talent• Collaborates with Human Resources (HR) and Talent Acquisition and provides input to develop retention strategies• Addresses employee concerns and partners with HR for resolution, as needed• Evaluates team performance and address gaps appropriately • Manages and develops direct reports from CQV team • Performs other duties, as assigned

Minimum Requirements:

• Master’s degree in engineering, Life Sciences, or a related field with 9+ years of experience in commissioning, qualification, and validation in the pharmaceutical or biotechnology industry. OR• Bachelor’s degree in engineering, Life Sciences, or a related field with 11+ years of experience in commissioning, qualification, and validation in the pharmaceutical or biotechnology industry.• 8+ years of people management & leadership experience• Experience and Strong knowledge of US and international regulatory standards and ICH guidelines especially with regards to data integrity. • Experience and knowledge of Electronic Validation systems such as KNEAT or similar.• Experience and knowledge of Lives Temperature Mapping systems or similar.

Preferred Requirements:

• Experience in large scale life science company. • Experience in green field project

Physical and Work Environment Requirements:

Will work in environment which may necessitate respiratory protection.

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to stand for prolonged periods of time up to 240 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

Will work in warm/cold environments.

Will work in outdoor elements such as precipitation and wind.

Will work in small and/or enclosed spaces.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).