Associate Director, CQV

FUJIFILM Diosynth Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Join a forward-thinking company as an Associate Director of CQV, where you will lead and execute critical validation activities in a state-of-the-art biologics manufacturing facility. This role is pivotal in ensuring compliance with regulatory standards while driving continuous improvement and optimizing processes. You will collaborate with diverse teams to enhance product quality and patient safety, making a significant impact in the life sciences sector. If you have a passion for innovation and a commitment to excellence, this opportunity is perfect for you.

Qualifications

• 9+ years of experience in CQV with a Master’s degree, or 11+ years with a Bachelor’s.
• Strong knowledge of regulatory standards and ICH guidelines.

Responsibilities

• Lead and execute CQV activities for biologics manufacturing compliance.
• Collaborate with cross-functional teams to optimize CQV practices.

Skills

Regulatory Compliance

Risk-based Verification

Leadership

Validation Lifecycle Management

Process Improvement

Education

Master’s in Engineering

Bachelor’s in Life Sciences

Tools

Electronic Validation Systems (KNEAT)

Temperature Mapping Systems

Job description

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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, CQV collaborates with cross-functional teams to drive continuous improvement and optimize CQV practices.

Company Overview
FUJIFILM Diosynth Biotechnologies is North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO. We are committed to manufacturing the next vaccine, cure, or gene therapy in partnership with innovative biopharma companies. Join us to be part of a culture that fuels your passion, energy, and drive—what we call Genki.

Job Description
What You'll Do

1. 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.
2. Ensures compliance with 21 CFR Parts 11, 210, and 211, ASTM E2500, ISPE Baseline Guides, and industry best practices.
3. Provides leadership for the risk-based verification approach, ensuring CQV programs focus on critical aspects affecting product quality and patient safety.
4. Collaborates with Quality, Engineering, Manufacturing, and Regulatory teams to ensure alignment on validation strategies and readiness for regulatory inspections.
5. Participates and represents CQV in new client or new molecule business proposal reviews and assists with onboarding of new molecules at the site level.
6. Leads presentations of FDBN’s Validation Lifecycle program during internal and external audits.
7. Chairs various steering committees such as process change board, change control board, PQ (Performance Qualification) council, etc.
8. Establishes Validation SOPs, Validation Project Plan (VPP), Validation Master Plan (VMP) to ensure full cGMP compliance by operations launch.
9. Provides guidance and leads the management of validation lifecycle using ASTM E2500 principles for all equipment, facilities, utilities, during IV/OV/IOQ/PQ phases, from GMP release to decommissioning.
10. Manages validation lifecycle activities, including URS development, DQ, risk assessments, FAT/SAT, and requalification.
11. Ensures integration of process validation (PV), cleaning validation (CV), and computerized system validation (CSV) into the overall CQV strategy.
12. Develops strategies for periodic reviews and requalification of equipment, utilities, and facilities to ensure cGMP compliance.
13. Oversees deviation investigations, change control evaluations, and continuous improvement initiatives within validation frameworks.
14. Provides CQV leadership for capital projects, ensuring timely validation activities within budget and schedule.
15. Leads external validation teams through commissioning, qualification, and validation of large-scale biologics facilities and equipment.
16. Manages CQV resource allocation, including internal teams and external contractors.
17. Drives process improvements to optimize CQV processes and reduce cycle times.
18. Ensures proper documentation control and approval processes for all validation deliverables.
19. Mentors and coaches team members, participates in recruitment, and collaborates with HR for retention strategies.
20. Evaluates team performance and addresses gaps as needed.
21. Performs other duties as assigned.

Minimum Requirements:

1. Master’s degree in engineering, Life Sciences, or related field with 9+ years of relevant experience, OR
2. Bachelor’s degree in engineering, Life Sciences, or related field with 11+ years of relevant experience.
3. 8+ years of people management and leadership experience.
4. Strong knowledge of US and international regulatory standards and ICH guidelines, especially regarding data integrity.
5. Experience with Electronic Validation systems such as KNEAT or similar.
6. Knowledge of Temperature Mapping systems or similar.

Preferred Requirements:

• Experience in large-scale life science companies.
• Experience with greenfield projects.

Physical and Work Environment Requirements:

• May require respiratory protection, hearing protection, and working in mechanical/production spaces.
• Ability to discern audible cues and perform visual inspections.
• Prolonged standing and sitting, repetitive motions, and working in various environmental conditions.