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Managing Consultant – Quality Assurance (m/f) - Berlin
12-12-2018

#Managing Consultant – Quality Assurance (m/f) - Berlin

As a Managing Consultant, you will be the first point of contact for all our clients’ questions and requests with regard to the development and maintenance of quality management systems. The regulatory standards our clients work with include GDP, GMP, GCP, ISO9001, and ISO13485. Together with your team, you will help clients apply for licenses as well as accompany them through audits, inspections and certification processes.  Our client spectrum includes large and small companies in the pharmaceutical and medical devices industry.


Responsibilities

  • You will be responsible for maintaining existing client relationships in line with the service portfolio.
  • You will effectively lead and further develop your team to maintain a high level of service for our clients.
  • You will be responsible for budget planning and ensure that revenue targets are achieved.
  • You will take over the function of “Responsible Person” according to §52 an AMG or as ”BtM Responsible” according to §5 BtMG or as “Qualified Person” according to §14 AMG or as Quality Management Representative for our clients.
  • Together with your team, you will:
    • help clients to identify processes that require quality management measures within their organisations build and maintain quality compliant systems/processes for clients.

    • prepare the necessary SOPs in accordance with the legal requirements and applicable standards.

    • prepare or review quality agreements.

    • conduct audits and coordinate inspections with the authorities for clients.

    • submit applications for dealer licenses or narcotics license on behalf of the clients as well as support and advice contract manufacturers /CMOs.

    • advise clients on quality issues and ensure compliance/implementation of quality guidelines.


Profile

  • You hold a university degree in Life Science, ideally in Pharmacy.
  • Ideally, you already held the functions as “Responsible Person” according to §52 AMG or as “BtM Responsible” according to §5 BtMG or as a “Qualified Person” according to §14 AMG or have professional experience as a Quality Management Representative.
  • You have several years of experience in quality management at a pharmaceutical company, a contract manufacturer organisation or a medical device manufacturer.
  • You have experience in managing projects and leading a team.
  • You possess strong analytical and organizational skills as well as problem-solving and consulting competence.
  • You have a sound knowledge of relevant national and international standards and guidelines in the pharmaceutical and medical device law. In addition, you are willing to continuously learn and expand your knowledge in this area.
  • You have a good command of written and spoken German and English.
  • You have very good MS Office skills.
  • You have very good communication and negotiation skills.
  • You are ready/open to travel to clients and other Xendo sites.
  • You have an entrepreneurial mindset.

 


We Offer

  • A diversity of interesting projects regarding different products with different clients
  • A flexible, dynamic and pleasant work atmosphere
  • Opportunities for learning and further development
  • Good terms of employment

 

If you are interested in this position, please send your complete application to Vivian Maumo-Ney: In case of any questions, please do not hesitate to get in touch with us. We are looking forward to your application!


 

 

 


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