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Senior Manager Quality Assurance (m/f) - Germany  

Amgen (company)


Posted on : 01 May 2017

Project Description

  • The Senior Manager Quality Assurance leads the local German Quality Team and is responsible for:
  • Acting as Responsible Person for wholesaling according to §52a German Drug Law and acting as the Graduated Plan Officer Quality according to §63a German Drug Law
  • Obtaining and maintaining pharmaceutical establishment licenses for wholesale distribution of company  products
  • Ensuring GMP/GDP compliance of all activities which fall under the accountability of company GmbH and maintaining full compliance to procedures and appropriate regulations
  • Management of product complaints, quality defects, product counterfeits & recalls on local level including the collaboration with the local supervising authorities in cooperation with Regulatory Affairs
  • Maintenance, review and further development of local Quality Management system ensuring regular process improvements and adaptation to changing legal environment
  • Ensuring that required Quality Agreements with subcontractors are in place and are up to date at any time
  • SOP writing on GDP/GMP related tasks and maintenance in controlled environment and proper record retention
  • Responsible for local training activities in the field of GDP/GMP
  • Managing and facilitating GDP/GMP inspections/audits and conduction of regular self inspections
  • Conduct of annual product reviews for medicinal products with a national/MRP/DC licence
  • Management of local company Quality team members including performance management and people development
  • Reporting to the General Manager of company GmbH on quality matters

Education and Experience:
  • Pharmacy Degree, Bachelor’s degree or equivalent degree in Pharmacy or Life Sciences
  • 5+ years of related professional experience in pharmaceutical environment and experience in the manufacturing of ready-to-use medicinal products
  • Knowledge of relevant German laws and regulations like German Drug Law, “AMWHV”, Arzneimittelhandelsverordnung and Law on Medical Devices as well as relevant European regulations and directives
  • Sound Knowledge of Quality Assurance principles, Guidelines on Good Manufacturing Practice (EU GMP) and Good Distribution Practice (EU GDP) of medical products for human use
  • Knowledge of the role of the European Medicines Agency (EMA) and use of EudraGMDP
  • Knowledge of the role of regulatory bodies and guidelines on “Advanced Therapy Medicinal Products” (ATMPs) is beneficial
  • Experience interacting with regulators and regulatory agencies is preferred
  • First Leadership experience is desirable

Skills and Knowledge:
  • Fluency in German and English language (both in oral and written communication)
  • Strong IS skills
  • Deep understanding of pharmaceutical business including customer needs
  • Access to pharmaceutical knowledge e.g. as member of respective German trade associations and/or professional industry groups
  • Strong analytical skills,D in particular with regard to complex rules, regulations and policies
  • Self-motivated, self-starter, results oriented, ability to work under time pressure
  • Strong negotiation, collaboration, persuasion, communication (written and spoken) and relationship building skills as well as presentation skills
  • Investigative and problem solving skills