Manager, R&D Quality Assurance- GCP Auditing

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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario.

Summary:

The Manager, R&D QA, Global Audits, Inspections and R&D Quality is responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The R&D QA Manager will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and provide key quality input to KK’s R&D function. 

Essential Functions:

•    Serve as key point of contact for GCP/GLP quality issues reported by KK staff and provides ongoing feedback to management on potential quality-related risks. Involvement in clinical trials includes, but is not limited to, independent review and approval of deviations and CAPAs, GCP guidance, and quality agreement preparation.
•    Perform and report assigned GCP/GLP audits of KK studies, including clinical investigator sites, vendors/CROs, internal systems/processes, and clinical data/documents, as applicable. 
•    Prepare timely, high-quality audit reports; evaluate audit responses; and oversee CAPA development, adequacy, implementation, and tracking in accordance with KK standards.
•    Maintain expert-level knowledge of global GCP/GLP regulations and industry expectations. Serve as a subject matter expert to KK staff, provide interpretation of regulatory requirements, and actively contribute to the company’s Regulatory Intelligence program.
•    Design and deliver GCP training to KK staff to enhance compliance awareness, inspection readiness, and quality culture.
•    Support continuous improvement initiatives; develop, revise, and administer SOPs and controlled documents; and ensure effective maintenance within quality document management systems.
•    Participates in Health Authority inspection activities for domestic and international projects (as applicable).
•    Provides input to the annual risk-based audit plan, schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
•    Undertake other QA-related duties as directed by the supervisor to support departmental and organizational objectives.

Requirements:

Education
Bachelor’s degree in Life Science or closely related scientific discipline (e.g., Pharmacy, Chemistry, Microbiology, Biology, or Pharmaceutical Sciences) required

Experience
•    Minimum three (3) experience in drug development in GCP/GLP Quality Assurance, including hands-on experience in auditing, CAPA management, and deviation review.
•    Demonstrated knowledge of global regulatory requirements, including EMA, FDA, MHRA, ICH, and other applicable standards, with proven ability to interpret and apply them in operational settings.
•    Experience supporting Health Authority inspections, including preparation, participation, and follow-up actions.
•    Proven track record in developing and implementing risk-based audit plans, SOPs, and quality systems, with experience in quality document management.
•    Experience in training and mentoring staff on GCP/GLP compliance and fostering a culture of quality.
•    Exposure to global, cross-functional collaboration with clinical, regulatory, and operational teams on QA-related matters.
•    Prior involvement in vendor/CRO management, clinical site audits, and quality agreement development is highly desirable.

Technical Skills
•    Experience with Veeva or other electronic Quality Management Systems (eQM