Specialist II, Quality Systems and Compliance

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 Specialist II, 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 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 conduct complex 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, the implementation of Quality Systems for the Site 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 progress against Site Quality System goals cross-functionally, and 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.
•    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.
•    Collaborate with multiple Quality Systems operations to ensure production targets are achieved compliantly within the Manufacturing, Warehouse, Engineering, and Laboratory areas. 
•    Member of a site-based inspection management team responsible for ensuring timely responses to local and international regulatory inquiries and requests, facilitating periodic GxP refresher trainings, and conducting regular walkthroughs of the GxP areas to ensure compliance and inspection readiness.

Requirements:

Education
•    Bachelor’s degree in life sciences (minimum)
•    Master’s degree in life science (preferred)

Experience
•    At least 3 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