VP, Manufacturing Quality

VP, Manufacturing Quality

Cepheid

Solna or Maurens-Scopont

The Vice President, Manufacturing Quality will provide leadership, overall strategic direction and operational coordination of activities for a multi-site Manufacturing Quality Operations team. This leader will serve as the management representative for the site operations and ensure compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements in alignment with company objectives and Quality standards. They will employ to utilization of Danaher Business Systems to drive safety, quality, delivery and productivity to products manufactured at all sites under a harmonized Quality Management System.

The Vice President, Manufacturing Quality will report directly to the Vice President, Global Quality and will supervise all operational sites in EMEAI including Solna, Bangalore and Chennai Quality organization encompassing the Quality Control, Quality Engineering, Quality Assurance and Quality Systems functions.

In this role, you will have the opportunity to:

  • Build, develop and manage a high performing Operations Quality team that includes Quality Control, Quality Engineering, Quality Assurance and site Quality Systems teams;
  • Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations. Ensure there are no significant interruptions to the business due to quality or compliance issues;
  • Build interface with Research and Development, Clinical Affairs, Regulatory Affairs, Manufacturing Operations and Commercial Operations to assure that product meets pre-launch, production and post launch requirements;
  • Lead site Change Management and Risk Management activities;
  • Communicates and reports regularly to Quality management, users and staff on the status of the quality system;
  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes.

The essential requirements of the job include:

  • Bachelor's Degree in engineering, biology, chemistry, or related field with 20+ years of experience; OR Master’s degree with 18+ years of experience;
  • Minimum 15 years of experience in In Vitro Diagnostics, quality engineering and/or quality systems in FDA regulated industry. Minimum 6 years of department lead experience in managing both processes, resources, and people;
  • Medical Device industry experience, preferably IVD;
  • Expert knowledge of US FDA and ISO requirements;
  • The ability to develop strategic goals and objectives from knowledge base and understanding of a customer’s business. Manage changing conditions, processes and approaches; lead organizations through change effectively;
  • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals;
  • Track record of measurable, operational improvements to Quality Systems related functions;
  • DBS, LEAN or Six Sigma operational excellence training or certification.

It would be a plus if you also possess previous experience in:

  • Training and/or certificates in quality or regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles);
  • Experience in Manufacturing Operations with managing large teams of Direct/Indirect labor;
  • Understanding of P&L management with strong financial and analytical skills;
  • Master or Ph.D. degree preferred with experience in Molecular Diagnostics.

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© EuroJobsites 2021

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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