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 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. Initially, position requires working on a construction site and will ultimately transition to the biotech manufacturing site in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role. May require up to 10% domestic and limited international travel The anticipated salary for this position will be $137,300 to $206,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 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 The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com . Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com . Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-SH1