Sr. Manager, CQV

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The Sr. Manager, CQV will be responsible for leading and overseeing all commissioning, qualification, and validation activities for facilities, utilities, equipment, and computerized systems supporting pharmaceutical manufacturing operations. This role ensures compliance with FDA, EMA, and global regulatory requirements, including GMP, GAMP 5, 21 CFR Part 11, and Annex 11, while supporting project delivery, operational readiness, and continuous improvement.

This role reports into the Director of Engineering 

Technical Skills, Knowledge, and Experience 
This role provides strategic direction, manages internal and external resources, and partners cross functionally to ensure validation activities are executed efficiently, compliantly, and aligned with business objectives. Experience using Valgenesis is a plus.

Leadership & Management
•    Lead, mentor, and develop a team of CQV and CSV engineers and specialists.
•    Establish departmental goals, performance metrics, and development plans.
•    Manage external consultants and validation service providers.
•    Serve as a subject matter expert (SME) for CQV/CSV across the organization.
Commissioning & Qualification (CQ)
•    Develop and implement commissioning and qualification strategies for: 
o    Manufacturing equipment
o    Process equipment
o    Facilities and cleanrooms
o    Critical utilities (HVAC, WFI, compressed gases, etc.)
•    Oversee execution of DQ, IQ, OQ, PQ activities.
•    Ensure traceability to user requirements and regulatory expectations.
•    Support startup, tech transfer, and commercial readiness activities.
Computer System Validation (CSV)
•    Lead validation of computerized systems including: 
o    Manufacturing Execution Systems (MES)
o    Laboratory systems (LIMS, CDS)
o    Quality systems (QMS, eDMS)
o    Automation and control systems (PLC, SCADA, DCS)
•    Ensure compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11
•    Approve validation plans, risk assessments, protocols, and final reports.
•    Oversee data integrity assessments and periodic reviews.
Compliance & Quality
•    Ensure validation lifecycle documentation meets regulatory and internal quality standards.
•    Support regulatory inspections and audits (FDA, EMA, MHRA, etc.)
•    Address audit observations, deviations, CAPAs, and change controls related to validation.
•    Drive risk based validation approaches and continuous improvement initiatives.
Project & Stakeholder Management
•    Partner with Engineering, IT, Quality, Manufacturing, and Automation teams
•    Support capital projects, expansions, and new product introductions.
•    Manage validation timelines, budgets, and resource planning.
•    Provide clear communication and reporting to senior leadership.

This role is a Manager of People

Education and Experience
•    The following combination of education and professional experience is required for this role:
o    Bachelor’s degree in a technical field required.  Formal GMP and Safety training is essential.  
o    At least 7 years of management / 8 years of senior management experience in pharmaceutical, biotech, or regulated manufacturing environments. Experience with Tech Transfer is a plus. 

Technical Skills
•    Proficient in MS Office Suite
•    Knowledgeable in cGMPs, GAMP, Safety Practices, Regulatory Compliance, Protocol Development and Execution, Risk Assessment, Criticality Assessment and System Turnover/Training. 

Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensit