Associate Director, CQV Position Available In Wake, North Carolina

Job Description:

FUJIFILM

Diosynth Biotechnologies is building the future ofbioproduction in Holly Springs, North Carolina. By end of 2025,we’ll open North America’s largest end-to-end CDMObiopharmaceutical manufacturing facility, offering drug substanceproduction, fill-finish, and packaging under one roof. We’relooking for passionate, mission-driven people to help us realizethis exciting vision and deliver the next vaccine, cure, ortherapy. We offer a dynamic work environment and we’re proud tocultivate a culture that will fuel your purpose, energy, anddrive—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 thrivingtech scene, making it the perfect blend of community andopportunity. What Youll Do

• Acts as CQV Technical Lead for theentire site to establish validation strategies, develop validationprocedures to align with FDB Large Scale Biologics platformoperating principles and regulatory requirements.
• Ensurescompliance with 21 CFR Parts 11, 210, and 211, ASTM E2500, ISPEBaseline Guides, and industry best practices.
• Provide leadershipfor the risk-based verification approach, ensuring CQV programsfocus on critical aspects affecting product quality and patientsafety.
• Collaborates with Quality, Engineering, Manufacturing,and Regulatory teams to ensure alignment on validation strategiesand readiness for regulatory inspections.
• Participates andrepresents CQV in new client or new molecule business proposalreviews and assists with onboarding of new molecules at the sitelevel.
• Leads presentations of FDBN’s Validation Lifecycle programduring internal and external audits
• Chairs the various steeringcommittees such as process change board, change control board, PQ(Performance Qualification) council etc.
• Establishes Validationstandard operating procedures (SOPs), Validation Project Plan(VPP), Validation Master Plan (VMP) to ensure full cGMP complianceby operations launch.
• Provides guidance and leads the managementof validation lifecycle using the

ASTM E2500

principles, for theentire site for all equipment, facilities, utilities, duringInstallation Verification (IV)/Operational Verification(OV)/Installation & Operational Qualification (IOQ)/ PerformanceQualification (PQ) through Good Manufacturing Practices (GMP)release to decommissioning

• Manages validation lifecycleactivities, including URS development, design qualification (DQ),risk assessments, FAT/SAT, and periodic requalification.
• Ensuresthe integration of process validation (PV), cleaning validation(CV), and computerized system validation (CSV) into the overall CQVstrategy.
• Develops the strategy for periodic reviews andrequalification of equipment, utilities, facilities to ensure cGMPcompliance
• Oversees deviation investigations, change controlevaluations, and continuous improvements within the validationframework, ensuring on-time closure and completion of complianceinitiatives
• Provides CQV leadership for capital projects,ensuring timely execution of validation activities within budgetand schedule constraints.
• Provides technical support and leadsteam of external validation engineers through commissioning,qualification and validation of large-scale biologics facilitiesand equipment.
• Manages CQV resource allocation, includinginternal teams and external CQV contractors.
• Drives continuousimprovement initiatives to optimize CQV processes and reducevalidation cycle times.
• Ensures proper documentation control andapproval processes for all validation deliverables.
• Coaches andmentors’ direct reports and team members to foster professionaldevelopment and growth
• Participates in the recruitment process toattract talent
• Collaborates with Human Resources (HR) and TalentAcquisition and provides input to develop retention strategies
• Addresses employee concerns and partners with HR for resolution, asneeded
• Evaluates team performance and address gaps appropriately
• Manages and develops direct reports from CQV team
• Performsother duties, as assigned

Minimum Requirements:

• Bachelor’s degreein engineering, Life Sciences, or a related field with 11 years ofexperience in commissioning, qualification, and validation in thepharmaceutical or biotechnology industry.
• Master’s degree inengineering, Life Sciences, or a related field with 9 years ofexperience in commissioning, qualification, and validation in thepharmaceutical or biotechnology industry. OR
• 8 years of peoplemanagement & leadership experience
• Experience and Strongknowledge of US and international regulatory standards and ICHguidelines especially with regards to data integrity.
• Experienceand knowledge of Electronic Validation systems such as KNEAT orsimilar.
• Experience and knowledge of Lives Temperature Mappingsystems or similar.

Preferred Requirements:

• Experience in largescale life science company.
• Experience in green field project

Physical and Work Environment Requirements:

• Will work inenvironment which may necessitate respiratory protection.
• Maywork in Mechanical/Production spaces that may require hearingprotection and enrollment in a hearing conservation program.
• Ability to discern audible cues.
• Ability to inspect or perform atask with 20/20 corrected vision, visual acuity, includingdistinguishing color.
• Ability to stand for prolonged periods oftime up to 240 minutes.
• Ability to sit for prolonged periods oftime up to 240 minutes.
• Ability to conduct activities usingrepetitive motions that include wrists, hands and/or fingers.
• Will work in warm/cold environments.
• Will work in outdoorelements such as precipitation and wind.
• Will work in smalland/or enclosed spaces.