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Global Quality Engineering Manager

vor 2 Monaten

Bern, Bern, Schweiz CSL Behring Vollzeit
About the Role

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. We are currently seeking a highly skilled professional to join our team as a Manager, Global Quality Engineering.

Key Responsibilities
  • Provide quality oversight of GMP-compliant realization of CAPEX and OPEX commercial portfolio projects at the CSL Behring site.
  • Review and approve risk analyses, user requirements, qualification plans, interim reports, and qualification protocols in CAPEX and OPEX projects.
  • Execute GxP supplier qualification activities and ensure compliance with regulatory guidelines.
  • Collaborate with Global Engineering and other stakeholders to ensure quality oversight and review of design activities and GxP documentation.
  • Analyze deviations and SQuIPP assessments related to engineering activities and determine corrective or preventive actions.
Requirements
  • Degree in life sciences and/or engineering; Advanced degree preferred.
  • 5+ years of experience as a professional in the pharmaceutical industry or equivalent combination of education and experience.
  • Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics.
  • Direct experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms and within a manufacturing and/or engineering context.
  • Strong quality process knowledge (SOP review & Approval, Deviation (oversight), Changes).
  • Experience in interacting with regulatory authorities including submissions and inspections.
  • Ability to influence at all levels of the organization through clear, concise and effective communication.
  • Good organizational and interpersonal skills.
  • Collaborate effectively with internal and external colleagues and stakeholders.
  • Experience in project-oriented working methods.
  • Effective use of German and fluent English skills (spoken and written).
About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Our Commitment to Diversity and Inclusion

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. We strive to create an environment where everyone feels valued, respected, and empowered to contribute their best work.