Global Senior Auditor Gcpglp QA

2 months ago

Marlow, United Kingdom Kyowa Kirin International Full time

Overview:
Senior Auditor, GCP/GLP QA, Global Audit, Inspections and R&D Quality

at Kyowa Kirin International

UK

**WE PUSH THE BOUNDARIES OF MEDICINE.**

**LEAPING FORWARD TO MAKE PEOPLE SMILE**

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

**Responsibilities**:
Key Responsibilities:

- Performs, reports assigned GCP/GLP audits of KK studies, including but not limited to clinical investigator sites, vendor/CROs, internal system/processes, clinical data and documents, 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
- Prepares timely well-written reports, obtains/evaluates audit responses and oversees tracking mechanism for QA audits and manages CAPA as per KK standards
- Provides ongoing feedback to management on potential quality-related risks
- Supports process improvement initiatives and maintenance of SOPs and other controlled documents in the quality document management systems
- Maintains high degree of knowledge of global industry expectations and GCP/GLP regulations to ensure high quality of audits performed
- Participates in Health Authority inspection activities for domestic and international projects (as applicable)
- Develops and delivers GCP-related training to KK staff as needed

Qualifications:

- Bachelor’s degree required and in science/life sciences preferred
- Strong experience in GCP/GLP auditing including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements
- Use of Veeva or similar QMS systems for electronic QA Management preferred
- Demonstrable ability to organise, prioritise, meet deadlines, make decisions, and change course of action quickly
- Strong interpersonal and communication skills
- Passion for personal learning and development to be able to grow with the company

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