Associate Director, CQV
Location: Holly Springs
Posted on: June 23, 2025
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Job Description:
FUJIFILM Diosynth Biotechnologies is building the future of
bioproduction in Holly Springs, North Carolina. By end of 2025,
we’ll open North America’s largest end-to-end CDMO
biopharmaceutical manufacturing facility, offering drug substance
production, fill-finish, and packaging under one roof. We’re
looking for passionate, mission-driven people to help us realize
this exciting vision and deliver the next vaccine, cure, or
therapy. We offer a dynamic work environment and we’re proud to
cultivate a culture that will fuel your purpose, energy, and
drive—what we call Genki. Ready to shape the future of medicine?
Let’s transform healthcare together! Holly Springs, North Carolina,
combines small-town warmth with proximity to Raleigh’s thriving
tech scene, making it the perfect blend of community and
opportunity. What Youll 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: • 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. • 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 • 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.
Keywords: , Cary , Associate Director, CQV, Engineering , Holly Springs, North Carolina
