Brookfield

Manager, Quality Engineering Method Transfer & Stability

Reporting into the Quality Engineering Methods Transfer & Stability Leader, the Methods Transfer & Stability Manager will provide QA oversight for projects covering methods transfer & stability. The individual will partner with the process and product owners of Capex projects at the Bern manufacturing site and will support QA oversight of quality standards and systems aligned with the Engineering functions in methods transfer, stability and cGMP compliance.

Role and Responsibilities

• Collaborate with internal and external partners for the execution of all capital projects – EU, AUS and US and others – to deliver projects on time and to the required standards and regulatory requirements
• Deliver a consistent quality approach to technology transfers and method transfers for capital projects
• Provide QA oversight within projects for the following areas:
• Methods transfer (method validation, analytical comparability)
• Stability (Intermediates, Drug Substances, Drug Products, Comparability)
• Container Closure Integrity Testing (Validation, Requalification)
• Material Qualification (Extractable & Leachables, Elemental Impurities)
• Support regulatory document submissions and pre-approval inspections for capital projects
• Collaborate with peers from Global Engineering across manufacturing sites with internal and external partners for the execution of all technology transfers and method transfers to deliver these changes on time and to the required standards
• Carries out quality decisions regarding technology transfers and method transfers which are aligned with the direction of the organisation
• Participate in risks assessments and ensures up-to-date information
• Ensures quality is represented appropriately for regulatory document submissions and regulatory inspections for technical transfer and the corresponding activities
• Delivers to global engineering standards and processes consistent with regulatory requirements and industry standards (quality systems, policies, procedures and work instructions)
• Provides input to Global Engineering on the content of an appropriate Documentation and Knowledge Management system for the Global Engineering function
• Delivers against global standards for technology transfer and method transfers
• Participate in deviations, SQuIPP assessment, ensure compliance of the final deviation reports

Skills and Experience

• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 6+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
• Experience within a global matrix organisation
• Knowledge of current Good Manufacturing Practices (cGMP) principles and Quality process knowledge (SOP review & approval, Deviation (oversight), Changes)
• Knowledge of appropriate regulatory requirements and experience in associated regulatory inspections
• Direct experience executing Quality Assurance function and system within a manufacturing and/or engineering context
• Exceptional communication skills, with the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organisation

Our Benefits

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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. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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