GxP Process Excellence Head

GxP Process Excellence Head

Sobi

Sweden or Switzerland

Role & Function

The GxP Process Excellence Head is accountable for the development and implementation of an enterprise-wide QMS excellence strategy covering end-to-end regulated processes conducted by Sobi functions, Affiliates, service providers and partners. The QMS excellence strategy delivers process integrity via compliant, effective, efficient end-to end process that increase HAs confidence in our QMS via adherence to GCP, GVP, GMP, GDP, GLP, MD and other applicable regulations adding value to Sobi and Sobi's patients.

Key Responsibilities

  • Lead the Process Excellence Team;
  • Responsible to provie partnership and compliance expertise to the process owners for the development and implementation of a comprehensive strategy for global, x-functional regulated GxP processes in terms of Global Process implementation strategy;
  • Responsible to proactively identify needs for process standardization, regulatory compliance direction and areas for improvement;
  • Accountable for the delivery of the QMS excellence strategy on processes in scope of their assigned domain for the conduct of GxP activities that deliver the SOBI's portfolio;
  • Responsible to provide expertise in analysis based on data driven decision making and metrics review to assess, prioritize and select improvement activities;
  • Responsible for the implementation and sustainability of Sobi Risk management process and for timely and strategic QMS process intelligence;
  • Ensure strategic partnership with business partners such as Global Process Owners, Function Leaders and SMEs at Global and Local level;
  • Accountable for strategies that deliver and operationalize critical infrastructure that improve efficiency and maximize Quality and business' ability to focus on value-add activities and accelerate delivery of quality solutions;
  • Accountable to ensure compliant, effective and efficient regulated processes are in place.

Qualifications

  • Minimum 15 years' experience from pharmaceutical industry within global Quality system, quality, manufacturing, product development and/or regulatory affairs;
  • Minimum 10 years leadership experience;
  • Pharmaceutical and medical device business understanding including in-depth knowledge about regulatory and GMP requirements;
  • Experience from working with improving business practices/working procedures;
  • Strong experience in digitalization for QMS;
  • Understanding of the pharmaceutical market interrelations and implications;
  • Experienced in working with high impact stakeholders, e.g. authorities, strategic business partners;
  • Experience from setting up and working with performance management, KPIs, including the management cycle;
  • Experience from working in an international organisation and across borders;
  • Green Belt certification.

Personal attributes

  • Strong in leadership and communication;
  • Proactive mindset and actions;
  • Strong interpersonal skills;
  • Good collaboration skills;
  • Result oriented;
  • Able to solve complex situations and problems;
  • Able to handle conflicts and create win-win situations;
  • Culture awareness and understanding the way of behaviour in different cultures;
  • Holistic business understanding;
  • Courage, empathy, trust, motivation;
  • Fluent in English.

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© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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