QA Manager / Responsible Person

at Kyowa Kirin International plc

Hoofddorp, Netherlands

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 act as responsible person for the Netherlands established Kyowa Kirin Wholesale Distribution Authorisations (WDAs).

Ensure that the provisions of the Kyowa Kirin Holdings B.V. Marketing Authorisations are supervised and products are supplied to the marketplace in compliance with cGDP requirements, company operating policies & procedures and business requirements.

This role is based in Hoofddorp, Netherlands

To act as the Responsible Person (RP).

The responsibilities of the responsible person include (as per EU Dir. 2001/83/EC and EU Guideline 2013/C 343/01):

• ensuring that a quality management system is implemented and maintained.
• focusing on the management of authorised activities and the accuracy and quality of records.
• ensuring that initial and continuous training programs are implemented and maintained.
• coordinating and promptly performing any recall operations for medicinal products.
• ensuring that relevant customer complaints are dealt with effectively.
• ensuring that suppliers and customers are approved.
• approving any subcontracted activities which may impact on GDP.
• ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• keeping appropriate records of any delegated duties.
• deciding on the final disposition of returned, rejected, recalled or falsified products.
• approving any returns to saleable stock.
• ensuring that any additional requirements imposed on certain products by national law are adhered to.

To support GDP audits for KKI contractors.

Provide regular reports of key performance indicators to senior management, as part of the Quality System, so that the appropriate resources can be allocated and corrective actions implemented, as necessary.

Ensuring all work is conducted in accordance with the company policy for Data Integrity.

Ensure, via a program of continuous professional development, up-to-date knowledge and expertise of current EU/local GDP requirements together with product specific training for the medicinal product(s) traded under the licenses.

• Eligible to act as RP under local and/or EU regulations.
• An academic degree or equivalent in Life Science, preferably pharmacist.
• Experience of dealing with manufacturing/distribution and GxP Quality Assurance requirements of Pharmaceuticals is essential.
• Have hosted regulatory inspections by EMA/local regulatory agencies.
• A broad experience of working within the Pharmaceutical Industry, ideally within a QA Management position at a manufacturing site.
• Familiar with the appropriate EU Directives, EU and USA regulatory processes, ICH Guidelines.
• Familiar with and experience of the implementation of Quality Management Systems e.g. ICH Q10.
• Knowledge of root cause analysis for failure investigation, quality risk assessment as per ICH Q9.
• Experience in translating corporate strategies into a regional and local context.
• Fluent in English, both verbal and written.
• A degree of flexibility needed with regards to rare occasions where working late/early might be required.
• Regular domestic travel and occasional EMEA/World-Wide travel.