Senior Specialist, GPV Performance Excellence in Marlow

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.

Job Purpose: This role supports with PV procedures and change controls management and monitoring. This role may coordinate all PV and certain PV vendor personnel training relevant to their roles and ensure that all Kyowa Kirin employees receive periodic PV training to enable the timely identification and reporting of adverse events.

Key Responsibilities:

• Coordinates PV procedures management through their lifecycle, including periodic review management, coordination of editing and review workflows in electronic document management system.
• Supports with periodic document management committee meetings preparation and conduct.
• Supports GPV stakeholders in change controls management.
• Performs PV procedures and change controls status monitoring and prepares periodic metrics.
• Maintains GPV training curricula across all PV job roles and coordinates the training of all PV and PV-relevant procedures for GPV personnel and certain PV vendor personnel.
• Monitors training compliance and prepares periodic training compliance metrics.
• Coordinates GPV personnel and vendor access to electronic quality document system.
• Supports with identification of opportunities for future performance optimisation and subsequent implementation of agreed initiatives, as applicable.

Position Requirements:

• High attention to detail and focus on quality.
• Previous experience working with multiple stakeholders within a complex matrix organisation.
• Previous experience in pharmaceutical, GCP and/or GVP related environment preferred.
• Previous experience in supporting projects preferred.
• Previous experience in managing reports and data preferred.
• Highly skilled in use of Microsoft Office applications and databases or electronic data management systems.
• Good communication and presentation skills. Proven skills in being accountable, impactful, and willingness to confront problems.

Kyowa Kirin International is an equal opportunities employer. No agencies please.