Senior Quality Management System Specialist

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

To participate in the implementation, execution, delivery and maintenance of the EMEA GxP Quality Management Systems and be the subject matter expert in the KK QMS, especially in VQD, VT, CSV and DI.

Key Responsibilities:

• Demonstrate expert knowledge of the KK QMS and its application to KK GxP licence compliance and product supply requirements.
• Support appropriate level of QMS GxP documentation reviews are carried out within KK, as necessary, to ensure ongoing QMS compliance.
• Key user on the electronic Quality Management System, including the role of System Administrator.
• Support QMS processes across EMEA, including delivering QMS training, as necessary, to ensure that staff are kept abreast of current Kyowa Kirin QMS requirements.
• Ensure global policies and procedures are incorporated within the EMEA QMS as appropriate.
• Monitor and provide regular reports of key performance indicators to KK management, as part of the Quality System, so that the appropriate resources can be allocated and actions are implemented, as necessary.

Position Requirements

• Life Science Degree qualified with substantial experience
• Specialist knowledge or experience of pharmaceutical QMS processes and practices.
• A broad experience of working within the pharmaceutical industry operating in a Senior Quality Assurance position at a manufacturing/distribution site.
• Excellent working knowledge of international QMS GxPs, especially in the interpretation of MHRA and FDA requirements, for the manufacture, control and distribution of commercial product and clinical trial materials
• Working knowledge of the regulatory requirements for validation activities as applied to computerised systems.
• Working knowledge of GxP requirements.

Physical Requirements:

• Worldwide travel as required.
• As this can be a sedentary position the individual needs to be able to withstand long periods of sitting.
• Ability to use VDU equipment.
• A degree of flexibility needed with regards to rare occasions where working late/early might be required.

Kyowa Kirin International is an equal opportunities employer.

No agencies please.