Senior Quality Manager

Basel Area
06 Dec 2018
06 Mar 2019
896096 - P
Contract Type

As an ideal candidate, you should have 3+ years of experience supply management with experience in supplier oversight and approval. As a Senior Quality Manager, you will provide QA oversight on all external suppliers, manage supplier qualifications, supplier changes, and quality agreements. In addition, the ideal candidate would assure compliance to cGMP standards is maintained for third-party management.

Main Responsibilities:

  • Responsible for initiating and driving supplier qualifications, upgrading of supplier qualifications from clinical to commercial;
  • Upgrading raw materials and consumables from clinical to commercial;
  • Overseeing all suppliers and raw materials used;
  • Managing quality aspects at external suppliers and ensure their compliance with GMP;
  • Managing and evualting change notifications from external suppliers;
  • Writing and implementing GMP relevant documents in area of responsibility (SOPs, Quality Agreement, APS);
  • Performing local implementation of Quality Manual and global procedures;
  • Managing projects, and providing QA support;
  • Representing the team in initiatives, liasing with key stakeholders across  the board to identify compliance standardization needs;
  • Providing support to line functions in GMP compliance related issues;
  • Ensuring that the required level of knowledge and skills are available and identify competency gaps, establish and implement training and development plans where necessary;
  • Meeting internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE, etc).

Qualifications and Experience:

  • Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent);
  • Fluent in English (oral and written) required; fluent in German desirable;
  • Strong ability to negotiate and communicate;
  • Sound scientific, technical and regulatory knowledge;
  • Excellent knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines;
  • Good knowledge of drug development and drug substance production;
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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