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Commercial Quality Operations Manager SEE

 

To oversee and assure Quality of the in-market operations in the STADA SEE in compliance with Global Policies and Procedures. To become the single interface between STADA Commercial Affiliates, Global Supply Chain and the QP Release Function in the SEE Region. 


Role & Responsibilities:

  • Responsible for assuring that the appropriate GMP / GDP systems and processes are in place to meet or exceed STADA Corporate and Regulatory Authority requirements for each region
  • To act as the Single Point of Contact between the market and STADA SEE
  • To coordinate the release of batches for distribution in the SEE market for customers where we distribute on their behalf
  • Work in partnership with other departments / functions to ensure proper support to product supply
  • Align Global Quality Strategies with Local Business Strategies
  • To develop an agile QA Organization able to react quickly and decisively to market requirements
  • Development of E2E Supply Chains for Key Products so that the knowledge and service level expectations are defined and understood
  • Investigate quality issues and/or review results provided by other departments
  • Gather, maintain and communicate Key Performance Indicators for quality assurance
  • Ensure products are released to the local market according to the proper requirements
  • Investigate, when necessary, customer complaints related to product quality and act as the conduit from the original manufacturer and the in-market customer
  • Act as the liaison between STADA SEE and Sanofi where we act on their behalf in the SEE markets
  • Manage the Sanofi rework process in the responsible countries
  • Release of reworked product in conjunction with releasing QP’s

 

Your profile:

  • University degree in pharmaceutical science, natural sciences, or related field
  • 5-10 years of experience in the pharmaceutical industry, in depth knowledge obtained in a similar role in QM / QA
  • Strong knowledge of Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP)
  • Strong understanding of Good Distribution Practice of medicinal products for human use (2013/C 343/01 and regulation 45 of the Human Medicines Regulations 2012)
  • Experience in the development and maintenance of a quality management system at a local and regional level
  • Strong understanding and experience of Pharmaceutical Supply Chains
  • Understanding of the QP Release Requirements in the EU and other non-EU Markets
  • Fluent English skills
  • Advanced level of knowledge of MS Office package
  • Fast learner and easily adaptable to changes
  • Team oriented, proactive individual thinking outside of the box
  • Experience in leading team and helping them reach their full potential

 

We offer:

  • Dynamic and responsible position
  • Continuous learning environment
  • Chance for a professional and personal development
  • Good working conditions and positive working atmosphere
  • Private health insurance

 

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