Senior Commissioning & Qualification Manager

Adryan B.V; Northern (KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Adryan seeks a seasoned CQV leader to shape and deliver the commissioning and qualification program for a highly ambitious, modular U.S. manufacturing campus. The role demands credibility in the boardroom, design office and field.

As Senior C&Q Manager, you will own the integrated CQV program from design through start-up, qualification and handover, building the delivery organization and leading client, EPCM, construction, automation and quality teams.

Qualifications

• 15+ years of CQV, validation, engineering or capital-project experience in FDA-regulated pharma/biotech manufacturing.
• Leadership of greenfield or major brownfield CQV programs with $300M+ capital value.
• Ability to build and lead large cross-company teams and manage GMP systems across multiple phases.

Responsibilities

• Own the integrated CQV Master Plan, system boundaries, turnover strategy and phase-specific execution plans.
• Shape the CQV delivery model early in the project to support modular design and future expansion.
• Manage CQV budget, schedule, risk, forecasting and executive reporting; protect critical path to licensure.
• Drive design reviews, FAT/SAT strategy, handover to operations and regulatory readiness.

Skills

CQV leadership

Project management

FDA/GMP knowledge

Executive communication

On-site leadership

Education

Bachelor's degree in engineering or life sciences

Tools

Kneat

ValGenesis

Job description

Lead the CQV strategy and execution for a major U.S. biopharmaceutical capital program.

• A pivotal leadership assignment on one of the biopharmaceutical capital programs in the United States.
• Direct influence over CQV strategy, organization, delivery standards and project outcomes.
• Backing of Adryan’s international CQV and quality network, with experienced teams across the United States and Europe.
• A competitive compensation package aligned with the seniority, duration and location of the assignment.

Adryan is seeking a seasoned CQV leader to shape and deliver the commissioning and qualification program for a highly ambitious, modular and expandable U.S. manufacturing campus. The assignment calls for a leader who has already delivered at comparable scale – someone equally credible in the boardroom, the design office and the field.

The role

As Senior C&Q Manager, you will own the integrated commissioning and qualification program from design development through construction completion, start-up, qualification, regulatory readiness and handover to operations. You will translate the project and quality strategy into an executable system-based plan, build the delivery organization and provide clear leadership across client, EPCM, construction, vendor, automation, quality and operations teams.

Responsibilities:

• Develop, maintain and govern the CQV Master Plan, system boundaries, system impact assessments, turnover strategy, test matrices and phase-specific execution plans.
• Create the CQV organization and resource plan; recruit, onboard and lead a multidisciplinary team of leads and engineers, including contractors and specialist vendors.
• Shape the CQV delivery model early in the project, ensuring that modular design, future expansion, procurement packages and construction sequencing support an efficient, right-first-time start-up.
• Own the CQV budget, integrated schedule, progress measurement, forecasting, risk register and executive reporting; protect the critical path to start-up and licensure.
• Establish a risk-based, science- and engineering-led delivery model aligned with ASTM E2500, ISPE guidance, FDA expectations, 21 CFR Parts 11/210/211 and applicable global GMP requirements.
• Drive design reviews, constructability and operability input, FAT/SAT strategy, mechanical completion, walkdowns, punch-list closure, commissioning, IQ/OQ and performance verification.
• Ensure vendor documentation and turnover packages are complete, traceable and inspection-ready; resolve deviations, changes and quality issues without losing delivery momentum.
• Integrate CQV with construction, automation/CSV, process validation, tech transfer, operational readiness, maintenance, training and site acceptance.
• Act as the senior CQV contact for project governance, Quality and regulatory inspections, and lead the final handover to system owners and operations.

Your profile:

• 15+ years of CQV, validation, engineering or capital-project experience in FDA-regulated pharmaceutical or biotechnology manufacturing, including substantial time in senior leadership roles.
• Demonstrated ownership of CQV on a greenfield or major brownfield program with total capital value of at least $300 million.
• Proven ability to build and lead large, multi-company teams and manage a portfolio of complex GMP systems across overlapping design, construction and start-up phases.
• Deep hands-on knowledge of facilities, HVAC/cleanrooms, clean and black utilities, process equipment, automation and computerized-system interfaces.
• Strong command of system-based turnover, risk-based qualification, schedule integration, budget control, change/deviation management and inspection readiness.
• Executive-level communication and stakeholder-management skills, combined with the practical judgment to resolve issues in the field.
• Bachelor’s degree in engineering, life sciences or a related technical discipline, or equivalent depth of relevant industry experience.
• Fluent English and eligibility to work in the United States. Regular on-site presence is essential.

Preferred experience

• Greenfield biologics, sterile manufacturing, cell therapy, advanced therapies or other complex multi-product manufacturing experience.
• Experience setting strategy during concept/basic design and carrying accountability through detailed design, construction and start-up.
• Working knowledge of digital CQV platforms such as Kneat or ValGenesis and integrated project controls tools.
• Experience with modular construction, large EPCM organizations and major U.S. permitting/construction interfaces.
• PMP, CPIP or comparable project/industry certifications.

Adryan is an equal opportunity employer. We welcome qualified applicants from all backgrounds.