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 Senior Specialist, Quality Systems and Compliance will play a critical role to ensure compliance with the 21 CFR Part 11 and Data Integrity requirements during the design, start-up, and lifecycle management of cGxP computerized systems to be implemented at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role will initially be involved working in a greenfield environment and will transition to provide technical expertise and leadership as an individual contributor within Quality Systems and Compliance team throughout the GMP-ready, Tech Transfer, and facility licensure activities for the manufacturing of Phase III and early commercial products. Accountable to plan, coordinate and conduct operational readiness activities and ensure compliance of the Quality Unit and Manufacturing operations with current GxP Standards and with all applicable Global, Regional and Site procedures within Kyowa Kirin’s Quality Management System.
Essential Functions:
• Lead and implement Site Quality System process in compliance with Global, Regional and Site GxP requirements maintaining patient-focus, sustainable compliance, and inspection-readiness for all GxP areas within the facility and laboratory areas.
• Monitor and report on progress against Quality Systems goals cross-functionally, to Site Leadership Team, and key stakeholders.
• Provide quality and compliance leadership collaborating cross-functionally in the site early-stage activities, including: facility detail design; review of facility, equipment and analytical instruments user requirements; prioritization for implementation of equipment, instruments and analytical methods required for facility start-up (GMP ready/OQ Complete); ICT efforts for developing user requirements and procuring selected electronic Quality Systems for the operations (LIMS/ELN/Empower) as well as configuration of the QMS in Veeva.
• Collaborate cross-functionally to ensure site compliance with current regulatory requirements for Data Integrity (ALCOA+), as applicable to paper and electronic records (21 CFR Part 11). Ensure design, implementation, and integration of GxP electronic systems according to the approved plans and budget in coordination with Global and Regional teams.
Requirements:
Education
• Bachelor’s degree in life sciences (minimum)
• Master’s degree in life science (preferred)
Experience
• At least 5 years of experience with technical leadership in GMP Bio-Pharmaceutical Quality teams, such as: Quality Systems, IT Quality, Quality Engineering, QA/QE Validation, Inspection Management, Lab QA, Logistics QA, etc.
• Experience with Tech Transfer, Computerized Systems Validation, Analytical Instruments Validation, Facility, Utility, and Equipment qualifications and maintenance program (Fit for Use).
• Experience implementing electronic systems in a Biopharmaceutical Manufacturing operation ensuring compliance with current GxP requirements with a strong focus on Data Integrity, ALCOA+, and 21 CFR Party 11.
• Experience leading and conducting investigation of nonconformances, in-depth understanding of the QMS procedures and relevant regulatory standards, as well as experience hosting, leading, and/or coordinating regulatory agency inspections of Bio-Pharmaceutical Manufacturing facilities and supporting areas.
• Experience with starting up a new facility is a plus. This includes facility design reviews, facility and equipment user requirements review, defining computerized systems requirements for the Manufacturing (MES/ERP/eBR/LIMS), Engineering (CMMS, eVAL, BMS), and laboratories (LIMS/ELN, Empower).
• Experience reviewing and approving Engineering Plans and GxP documentation in support of the equipment, facilities, and processes qualification efforts (Validation protocols, reports, test plans, Project Verification Plans, Validation Master Plans, Site Master File, etc.).
Technical Skills
• Proficient in MS Office Suite, and Lean Labs or Agile Lean.
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.
