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 Specialist, Quality Assurance will play a critical role in the start-up, and operations of the Quality Assurance organization within 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 leadership to the Quality Assurance organization 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:
• Provide quality assurance leadership collaborating cross-functionally in the site early-stage activities, including user requirements review; prioritization for implementation of equipment, instruments and analytical methods required for facility start-up and selected electronic Quality Systems for operation (LIMS/ELN/Empower).
• Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Assurance procedures as applicable to stand up the Site QMS and develop GxP training requirements for QA Staff.
• Establish a Site Risk Management procedure 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 and coordinate cross-functionally the robust and compliant and timely implementation of the required Site GxP procedures in support of the QMS and Contamination Control Strategy.
• Establish procedures for batch record review, product quarantine, and disposition in compliance with all applicable regulatory requirements (JP, USP, EP, Annex 1, CFRs, etc.).
• Provide technical expertise in Quality Assurance to all GxP operations within the Manufacturing, Warehouse, Engineering, and Laboratory areas, to ensure production targets are achieved compliantly.
• Review and approve all required validation and qualification activities for the facility, equipment, analytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.
• Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) requirements as applicable to paper and electronic records (21 CFR Part 11).
• Onboard, train, and mentor QA employees and/or contractors per approved staffing plans.
• Lead and ensure timely investigation of non-conformances, deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate actions (CAPA) for diligent and effective resolution.
• Establish key performance indicators for Site Quality Metrics including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM Data trends, Stability Trends, Product Disposition Cycle-times, etc.).
• Provide subject matter expertise and leadership to establish a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for all GxP areas within the facility and laboratory areas.
• Develop, approve, monitor, and communicate progress against goals cross-functionally and to Site Leadership Team, and key stakeholders.
Requirements:
Education
Bachelor’s degree in life sciences (minimum)
Master’s degree in life science (preferred)
Experience
• At least 5 years of experience in Quality Assurance Biopharmaceutical Manufacturing operations, providing technical and compliance leadership to GMP Bio-Pharmaceutical Quality Assurance teams, such as: QA Document Control, QA Training, QA Inspections, QA Batch Disposition, QA Shop Floor Teams, Lab QA, Quality Agreements Team, QA Vendor Qualification Team, Incoming Quality Assurance, Logistics QA, etc.
• 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 providing QA expertise to 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.
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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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#LI-TT1 #Sanford #North Carolina #On-Site
