Manager, Global Quality Engineering (100%)

at  CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.
For our Bern Site, we are currently looking for a

YOUR SKILLS AND EXPERIENCE

• Degree in life sciences and/or engineering; Advanced degree preferred
• 5+ years of experience as 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)
  We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of reference and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
  CSL Behring is committed to providing equal employment opportunities for all.

• Support Global Engineering (Process Engineering & Project Delivery) in the following fields during project phases: Vendor Qualification, Commissioning & Qualification, Process Life Cycle, Methods Transfer and Stability
• Quality oversight of the GMP-compliant realization of CAPEX and OPEX projects
• The role will focus on Commissioning & Qualification and Process Life Cycle activities
• The incumbent is responsible for Commissioning & Qualification, focusing on:
• Determining the requirements for the quality of supply and manufacturing systems and rooms while taking the Process Design into account
• Review and approve risk analyses, user requirements (URS), qualification plans, interim reports, and qualification protocols in CAPEX and OPEX projects
• Execution of GxP supplier qualification activities
• Process Life Cycle :
• Quality oversight for technology transfers (risk assessments, protocols and reports) and Quality by Design (QbD)
• Quality Oversight for PPQ validation and support studies, cleaning validation, life cycle management
• The incumbent works closely with members of Global Engineering and supports the other Global Quality Engineering fields
• QA Manager for local and global change requests related to engineering activities
• Analyse deviations and SQuIPP assessments related to engineering activities and determine corrective or preventive actions to correct the deficiencies and avoid their occurrence in the future