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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.
Summary:
The EQV/CSV Lead will lead the Commissioning, Qualification and Verification of our NC Manufacturing Facility. Post project implementation, the EQV/CSV Lead will be responsible for EQV/CSV activities at the site as it transitions into routine operations. In this role, you will collaborate closely with our team, demonstrating compassion and integrity in all your work. You will utilize your ability to facilitate alignment among diverse viewpoints to make informed decisions and drive consensus. By fostering a positive and inclusive environment, you'll navigate change and uncertainty with resilience and clarity, contributing to your team's ability to adapt to rapidly evolving, fast-scaling environments and meet new challenges in the biotech industry.
Essential Functions:
• Develop the establishment of the EQV/CSV program for the Sanford site.
• Supports the implementation of selected e-validation solution.
• Drives execution with the other functional leads of the capital project, delivering an ‘OQ complete’ status of the facility by Q1 2027
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 is a must. Experience with Tech Transfer is a plus. Background in cGMP regulations, GAMP, EHS.
Technical Skills
Proficient in MS Office Suite
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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Top Skills
What We Do
Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. We work on some of the hardest to treat diseases where need is high, and potential for life-changing impact is possible.
The North America organization includes three offices in New Jersey and California that focus on drug discovery, product development, and commercialization. Together, we work as a collaborative team to understand clinical needs and advance innovations that have a profound impact on patient lives.
Our growth in North America relies on entrepreneurial team players who are willing to share their expertise and ideas in an environment that prioritizes innovation, diversity, integrity and “wa.” Each person plays a significant role in shaping the work we do and the results we deliver.
