Associate Director, CQV Lead

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey, North Carolina and California) that focus on drug discovery, product development, manufacturing and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary:

The CQV Lead will lead the Commissioning, Qualification and Verification of the NC Manufacturing Facility.  The CQV Lead will also be responsible for developing and implementing the Operational Readiness Program to enable safe, timely, and compliant production of Drug Substance by 2027.    
Post project implementation, the CQV Lead will be responsible for CQV activities at the site as it transitions into routine operations.   

Essential Functions:

•    Provide C&Q input to design development as part of the KKNA project team.
•    Selection of and management of third-party C&Q and Operational Readiness service provider(s).
•    Planning and coordination of C&Q activities with third party provider in line with current industry best practice and risk-based approach (ISPE, ASTM E2500).
•    With C&Q service provider, track progress in line with agreed schedules to enable delivery of overall program including from a safety and compliance perspective.
•    Planning and coordination of Operational Readiness activities with third party provider in line with current industry best practice.
•    Alignment of Operational Readiness outputs with overall facility start-up plan to deliver an aligned and seamless execution-ready state.

Requirements:

Education
Bachelor’s degree in a technical field required.  Formal GMP and Safety training is essential.  

Experience
At least 10 years of experience in CQV for BioPharma Manufacturing or Capital Projects.  Leadership experience in CQV and Operational Readiness is a must.  Experience with Tech Transfer is a plus.  Background in cGMP regulations, GAMP, EHS, permitting, is required.   

Technical Skills
Knowledgeable in: cGMPs, GAMP, Safety Practices, Regulatory Compliance, Protocol Development and Execution, Risk Assessment, Criticality Assessment and System Turnover/Training. 

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.

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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.

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