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Associate Director Quality Management - Germany
Posted on : 01 May 2017
- The Associate Director Quality Management will act as a Qualified Person in accordance with EU GMP to provide final certification/release of clinical and commercial pharmaceutical products along with Quality Assurance and Regulatory support.
- While based at our 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 International Quality Assurance team and will manage the International GMP/GDP compliance program.
- 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 company Bio sciences 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 company Bio sciences Germany site
- Interact with the local Bavarian Authorities as it pertains to the company Germany Licenses and GMP/GDP activities
- Company International Compliance Program responsibilities include:
- Develop and manage the International GMP/GDP vendor audit program
- Develop and manage the 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
- Supply Chain
- CMO QPs
- 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