Chief Quality Assurance Officer, Biopharmaceuticals

5 days ago


Uppsala, Uppsala, Sweden Danaher - Global Full time

About Danaher - Global

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Danaher is a world leader in the life sciences industry, providing innovative solutions to accelerate your potential. We are seeking an experienced Quality Assurance Professional to lead our Uppsala site Quality Assurance organization and Quality Management System (QMS).

This role will report directly into the Global QARA organization and is based onsite at our Uppsala site.

Job Description

  • Lead Quality Management Representative responsible for the leadership & development of the Uppsala QA function.
  • Global Process Support, represent the needs of the site during change management and continuous improvement discussions.
  • Accountability, set & monitor Quality KPI's including reporting on performance/trend insights within business reviews.
  • QA Support, ensure adequate QA support to Site Projects, including new product development.
  • Procedures and Systems, ensure QMS procedures, work instructions, and IT System effectively support the Uppsala organization - Collaborate with Global QMS systems, documentation control and training leaders as required.
  • Cross-Functional Collaboration, coach/mentor Uppsala associates on QMS requirements.

Requirements

  • Bachelor's Degree in a Science or Engineering discipline.
  • Quality Assurance Experience working in Life Science, Medical Device or Biopharma manufacturing environments.
  • Senior Leadership experience within Quality Assurance/Quality Engineering.
  • ISO Knowledge, comprehensive understanding of ISO 9001 & ISO 13485 requirements.
  • Communication Skills, excellent communication skills (written and oral), fluent in both Swedish & English.
  • Project Management, experienced in managing project teams and working cross-functionally, both locally & globally.
  • Analytical Skills, exceptional analytical, problem-solving & root-cause analysis skills.
  • Product Life Cycle, demonstrated expertise to effectively communicate within all levels of the organization around the entire product life cycle management (design controls, verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management, services).
  • Continuous Improvement, experienced in continuous improvement methodologies & tools (i.e. LEAN six sigma, DBS, SPC and data trending).

Preferred Qualifications

  • GMP Requirements.


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