Associate Director GPV Performance Excellence – Optimisation Team

at Kyowa Kirin International plc

Marlow, UK (hybrid)

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.

Job Purpose:

You will work closely with GPV and cross-functional stakeholders to ensure deviations are appropriately managed, remediated and reported. You will support GPV with audit co-ordination and oversee the management of all PV CAPA arising from audits, deviations, inspections and stand-alone process improvements, ensuring timely verification of actions, long-term effectiveness, as well as strategic remediation of high-level trends and risks

Key Responsibilities:

• Ensures GPV deviations are managed well
• Contributes to the design and implementation of audit preparation
• Identifies and engages key subject matter experts to participate in audit preparation and management activities
• Contributes to regular reports to PV leadership on the status of the audit, deviation and inspection outcomes and commitments, escalating issues as required
• Contributes to late-log reporting interface with GPV Operations sub-function to support with remediation and proactive identification
• Supports cross-functional GPV interface with Global Audits
• Maintains an in-depth knowledge of role-relevant electronic systems, i.e. Veeva Quality Documents and global safety related regulations including (but not limited to) EMA, FDA, PMDA, ICH, CIOMS
• Serves as a strategic thought partner to the Global Head PV Performance Excellence on future strategies of performance optimisation

Position Requirements:

• Strong experience in pharmaceutical, GCP and/or GVP related performance excellence environment.
• Strong experience of managing people and process management in GCP and/or GVP performance excellence
• Experience in managing complex organisational compliance issues and in identifying, implementing and leading organisation-wide compliance initiatives
• Outstanding communication and presentation skills. Proven track record of leadership, accountability, impact, people management and willingness to confront complex problems.

Kyowa Kirin International is an equal opportunities employer.

No agencies please.