Sr. Manager, CQV
The Senior Manager, Commissioning, Qualification, and Validation (CQV) at Kyowa Kirin North America is responsible for leading and overseeing all CQV 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. The position reports to the Director of Engineering.
Key responsibilities include developing and implementing commissioning and qualification strategies for manufacturing and process equipment, facilities, cleanrooms, and critical utilities. The role involves overseeing the execution of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, ensuring traceability to user requirements and regulatory expectations. Additionally, the Senior Manager will lead the validation of computerized systems, such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), and automation and control systems, ensuring compliance with relevant regulations.
The ideal candidate will possess a bachelor's degree in a technical field, formal GMP and safety training, and at least 7 years of management experience in pharmaceutical, biotech, or regulated manufacturing environments. Proficiency in MS Office Suite and knowledge of cGMPs, GAMP, safety practices, regulatory compliance, protocol development and execution, risk assessment, criticality assessment, and system turnover/training are essential. Experience with tech transfer and using Valgenesis is a plus.
The anticipated salary for this position ranges from $137,300 to $206,000 annually. Kyowa Kirin North America offers a comprehensive benefits package, including a 401K with company matching, an annual bonus program, generous PTO and holiday schedules, healthcare benefits, HSA & FSA programs, well-being and work/life programs, life and disability insurance, concierge services, pet insurance, tuition assistance, and employee referral awards.
Kyowa Kirin North America is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in areas such as bone and mineral, intractable hematologic, hematology oncology, and rare diseases. The company is headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Employees are encouraged to share their expertise and ideas in an environment that prioritizes innovation, diversity, integrity, and collaboration.