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 Sr Manager, 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 lead 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 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:
• Assist the Site Quality Head in coordination with Global and Regional teams, leading efforts to establish and maintain a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for all GxP areas within the facility and laboratory areas.
• Assist the Site Quality Head developing, approving, and communicating the quality goals and objectives for the site, in coordination with Global and Regional teams. Ensure progress against goals is monitored and reviewed with 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.
• Ensure Quality Systems adhere to Global, Regional and Site Risk Management procedures seeking to ensure a consistently robust and compliant methodology is implemented for the documentation of risk-based approaches and decisions based on sound rationales, with justifications supported by facts and data.
• Lead all Quality Systems operations to ensure production targets are achieved compliantly within the Manufacturing, Warehouse, Engineering, and Laboratory areas.
• Lead, review, and approve of all required validation and qualification activities for the facility, utilities, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.
• Implement a site-based inspection management team responsible for ensuring timely responses to local and international regulatory inquiries and requests, coordinating periodic GxP refresher trainings, and coordinating regular walkthroughs of the GxP areas to ensure compliance and inspection readiness.
• Hire, onboard, train, and mentor QS employees and/or contractors per approved staffing plans.
• Establish key performance indicators in coordination with Global and Regional teams, to monitor Site performance against QMS requirements and coordinate periodic site management review with Site Leadership team.
Requirements:
Education:
Bachelor’s degree in life sciences (minimum). Master’s degree in life science (preferred). Experience with starting up and operating a biopharma manufacturing facility is a plus.
Experience:
At least 7 years of management experience leading 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, 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 non-conformances, 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 and managing a quality team at 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, Lean Labs, or Agile lean.
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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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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.
