Associate Director GMP/QP
Kyowa Kirin International
To support Kyowa Kirin Holdings B.V. (KKH) for maintenance of the established MIA (Manufacturing Import Authorization), perform batch release and certification of commercial products in the EU in accordance with EU GMPs Annex 16 and to ensure the compliance with cGMDP requirements.
The incumbent will be managing regulatory inspections of KKH and support continuous development of the established KKH Quality Management System, specifically in relation to batch release and certification.
Empowered to interact with Dutch and European Authorities as it pertains to the KKH Licenses and GMP/GDP activities.
Maintain KKH’s GMP regulatory license and ensure that the provisions of the KKH MIA is observed;
Contribute to ensure that KKH’s QMS is effectively established and maintained in order to support the active licenses (MIA, WDA and CDL) in compliance with Eudralex vol. 4, the EU Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use, 21 CFR part 210/11 and Global Kyowa Kirin Quality Standards;
Implement all Kyowa Kirin Global/Regional Policies and Procedures relevant to the KKH’s activities;
Perform KKH internal and external audits;
Perform QA oversight activities as described under the KKK QMS and provide regular reports of KKH key performance indicators, as part of the Quality System, so that the appropriate resources can be allocated and corrective actions implemented, as necessary;
Ensuring that any additional requirements imposed on certain products by national law are adhered to;
Ensure Global Quality Plan and/or activities are executed according to plan for commercial KKH GMP/GDP activities;
Ensure, via a program of continuous professional development, up-to-date knowledge and expertise of current EU/local GMP/GDP requirements together with product specific training for the medicinal product traded under the licenses.
EU/EEA Qualified Person responsibilities
To be named on the KKH MIA;
Batch certification and release of commercial products in the EU in accordance with EU GMP Annex 16;
Importation of product from third countries;
Provides QP GMP declarations in support of regulatory filings;
QP review and evaluation of deviation, complaints, change controls, PQRs;
Perform QP audits;
Establish QP to QP agreements when required.
EU/EEA Responsible Person
Act as back-up of RP for Kyowa Kirin Holdings B.V. (KKH) & Kyowa Kirin Pharma B.V. (KKP);
To be named on the KKH WDA & KKP WDA;
Fulfill RP task in accordance with 2013/C343/01;
To fulfil RP responsibilities personally and be continuously contactable in back-up role.
Eligible to act as QP and RP under EU regulations;
An academic degree or equivalent in Life Science, preferably Pharmacist;
Experience in QA for international pharmaceutical industry with at least 3-5 years’ experience as QP;
Experience in release of commercial product of different pharmaceuticals forms. Experience with biotech/sterile products is an asset;
Experience of dealing with quality assurance, manufacturing and distribution requirements of Pharmaceuticals is essential;
Thorough knowledge in cGMDP and global regulatory requirements (US, EU, JP) – EU Directives, EU and USA regulatory processes, ICH Guidelines (Quality Management Systems e.g. ICH Q10 & root cause analysis for failure investigation, quality risk assessment);
Have hosted several regulatory inspections by IGJ, EMA, FDA and other regulatory agencies;
Results Oriented, Sense of Urgency and Flawless in Execution;
Good interpersonal and good verbal/written communication skills;
Good analytical and strong problem-solving skills;
Results focused which may require negotiating skills, empathy, diplomacy and common sense;
Team player and ability to work with local and remote teams;
English fluency written and spoken. Fluency in Dutch is an advantage;
Ability to travel up to 25%.
Don’t forget to mention EuroPharmaJobs when applying.
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