Sr. Manager, CQV

Kyowa Kirin North America•Sanford, NC

4d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in a technical field required. Formal GMP and Safety training is essential.
At least 7 years of management / 8 years of senior management experience in pharmaceutical, biotech, or regulated manufacturing environments.
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.
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 sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

Nice To Haves

Experience with Tech Transfer is a plus.
Experience using Valgenesis is a plus.

Responsibilities

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.
Develop and implement commissioning and qualification strategies for:
Manufacturing equipment
Process equipment
Facilities and cleanrooms
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.
Lead validation of computerized systems including:
Manufacturing Execution Systems (MES)
Laboratory systems (LIMS, CDS)
Quality systems (QMS, eDMS)
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.
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.
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.

Benefits

401K with company matching
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Long-Term Incentive Program (subject to job level and performance)
Life & Disability Insurance
Concierge Service
Pet Insurance
Tuition Assistance
Employee Referral Awards