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Associate Director Quality Management Munich Germany,  

Posted on : 01 May 2017

Project Description

   The Associate Director Quality Management will act as a Qualified Person in accordance with EU GMP to provide final certification/release of Incyte clinical and commercial pharmaceutical products along with Quality Assurance and Regulatory support. While based at our Incyte Germany office the role will also include Responsible Person responsibilities for the Quality oversight of commercial product distribution in Germany. The Associate Director Quality Management is a member of the Incyte International Quality Assurance team and will manage the Incyte International GMP/GDP compliance program. Key Responsibilities  EU/EEA Qualified Person responsibilities include: Day to day batch release and certification of commercial product in the EU to ensure the batch and its manufacture comply with the GMP and provisions of the marketing authorizations Day to day batch release and certification of IMP destined to European clinical trials to ensure the batch and its manufacture comply with the GMP, product specification file and clinical trial applications Maintenance of a Batch Register Providing QP GMP declarations in support of importation and regulatory activities Ensuring that the principal manufacturing and testing processes have been validated QP review and evaluation of deviation, complaints, change controls, PQRs Performing QP audits Establishing QP to QP agreements when required Be continuously contactable   Germany Qualified Person/Responsible Person responsibilities include: Establishment and maintenance of the Incyte Biosciences Germany QMS and ensure a state of inspection readiness Batch release to the German market German distribution quality oversight Performing self-inspection and ensuring GMP and GDP compliance at the Incyte Biosciences Germany site Interact with the local Bavarian Authorities as it pertains to the Incyte Germany Licenses and GMP/GDP activities   Incyte International Compliance Program responsibilities include: Develop and manage the Incyte International GMP/GDP vendor audit program Develop and manage the Incyte International GMP/GDP Internal audit program Verify that all audits have been carried out as required by the quality assurance system, and extend support to team when required. Maintain knowledge of current guidelines and GMPs in line with duty for continual professional development and to establish a regulatory compliance watch Provide expert review of CMC submissions   Interface: Supply Chain CMO QPs CMO RA-CMC   Requirements The candidate must be fully qualified QP with experience of final certification/release within the EU/EEA. Quality systems management, audit experience (internal and external) and a strong EU regulatory understanding are also essential for this role. A good knowledge of Quality Systems (compliance, CAPA, continuous improvement) and importation would be advantageous. The ideal person will have the experience and the confidence to interact with QA and Regulatory teams and will have the strength of character to guide teams of professionals. Small molecule and biotech large molecule QP experience would be a distinct advantage but applications from QPs that have had exposure to a broad range of activities are welcome. Graduate, preferably in Chemistry, Pharmacy or Biological Science. Wide ranging technical knowledge and experience within the pharmaceutical industry. Substantial previous Quality Assurance experience Excellent scientific and technical knowledge Is multi-skilled across a number of areas and has developed specialist expertise relevant to function. Up to date knowledge of cGMP, cGDP and regulatory expectations Team player and ability to work with remote teams Travel up to 30% English fluency written and spoken (the company language) Strong verbal and written communication skills with well-structured communication and presentation ability Strong interpersonal skills  



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