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.

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.

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-TT1 #Sanford #Carolina