Manager, GCP/GLP QA

Kyowa Kirin International

Marlow, United Kingdom

Responsibilities:

Job Purpose:

You are responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The GCP/GLP 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 GCP/GLP QA Manager will collaborate and provide key quality input to KK’s R&D function.

Key Responsibilities:

Acts 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
Maintains high degree of knowledge of global industry expectations and GCP/GLP regulations to act as a key point of contact for KK staff, providing information and expert guidance on regulations and procedures
Develops and delivers GCP-related training to KK staff as needed
Supports process improvement initiatives, develops/administers SOPs
Participates in Health Authority inspection activities for domestic and international projects (as applicable)
Performs, reports assigned GCP/GLP audits of KK studies
Provides input to the annual risk-based audit plan, schedule and execution of audits
Prepares timely well-written reports, obtains/evaluates audit responses and oversees tracking mechanism for QA audits and manages CAPA

Qualifications:

Position Requirements:

Bachelor’s degree required in science/life sciences preferred
Strong experience in drug development and strong experience in GCP/GLP Quality Assurance including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements
Proficiency in MS Office Suite is essential
Use of Veeva or similar QMS systems for electronic QA Management preferred
Good working knowledge of international GxPs

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