Manager, Global Quality Engineering

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

For our Bern Site we are currently looking for a

The Manager Global Quality Engineering is responsible for quality oversight of GMP compliant realization of CAPEX and OPEX commercial portfolio projects at the CSL Behring Bern.

This role will provide quality oversight and review of design activities and GxP documentation for of CAPEX & OPEX commercial portfolio projects at the CSL Behring Bern site relevant to Global Engineering.

Key Responsibilities

• 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 :
  • o Quality oversight for technology transfers (risk assessments, protocols and reports) and Quality by Design (QbD)
  • o 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

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.