COMPLETE Associate Director & Head of GLP/GCLP Quality (EU) - EMEA, DE, Marburg, CSL Behring

The Opportunity

You will ensure regulatory compliance to GLP, ISO/IEC 17025, GCLP, GRLP activities and other GxP requirements (as applicable) for CSL in the EU. You will develop inspection readiness activities, manage the ongoing requirements for GLP/GCLP R&D Quality Systems, and R&D Quality and lead quality projects and taskforces as they arise from different sources and issues.

The Role

• Provide guidance in GLP, GCLP, GRLP & GxP best practices to ensure that R&D employees are aware of quality requirements
• Ensure regulatory compliance with OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.
• Manage GLP/GCLP QS for EU ensuring procedures are in line with Global R&D Quality.
• Primary representative for R&D Quality on site quality management forums and discussions (EU)
• Develop phase appropriate quality systems
• Primary EU representative for GLP/GCLP for Change Control Panel (as required)
• Track and trend R&D Quality Measurements for GLP/GCLP EU
• Apply GLP/GCLP Management System for Research, Pre-Clinical and Clinical Phases (I/II/III) where appropriate
• Develop and implement inspection readiness programmes ensuring consistency across programs and regions
• Maintain the execution of inspections following the GLP and ISO 17025 Inspection (inc. GRLP) Schedule as it applies to relevant departments
• Conduct ISO 17025 inspections and GLP process inspections, facility inspections, study inspections and document inspections to determine if all studies are conducted in compliance with the OECD Principles of GLP; report inspections findings and improvement recommendations to relevant departments
• Ensure all inspection findings are reported to Test/Site Facility Management and Study Director and Principal Investigator as applicable to relevant departments for Plasma and Recombinant Product Development and Gene Therapies
• Host external GLP and GCLP (ISO/IEC 17025) regulatory inspections
• Management of Corrective and Preventive Actions (CAPA) for compliant responses to findings and their closeout·       Track and trend finding responses for GLP and GCLP (ISO/IEC 17025) regulatory inspections
• Support Global Research and Clinical Pharmacology and Translation Development and provide assurance to the company that the regulated and non-regulated scientific research or early phase non-clinical and clinical activities undertaken comply with applicable regulatory requirements, relevant industry standards and company policies and SOPs
• Support the GLP/GCLP vendor audit programme for GLP/GCLP by performing audits in the
• Support R&D partners with change, deviation and CAPA management·       Facilitate GxP assessments for R&D equipment and facilities
• Help develop global Quality Management Review for GLP/GCLP and Early Development Process control stream·       Build business relationships with local and global R&D Quality sites to ensure agreement on quality inspections
• Educate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development·       Partners with the R&D Quality LT and Head of R&D Quality Management Systems to establish appropriate QMS framework and GxP appropriate procedures
• Mentor team members to provide support across the site to ensure compliance with regulatory requirement and global policies
• Participate in continuous improvement activities including global harmonisation projects.Support projects and new system implementations

Your skills and experience

Degree in relevant biological science

10+ years experience in one of the following: R&D Quality (GLP and/or GCLP)

Influencing key stakeholders related to inspection readiness and compliance with regulations

Knowledge of OECD Principles of GLP

Knowledge of ISO/IEC 17025 – Testing and Calibration Laboratory Requirements

Experience and knowledge in the application of Quality Systems

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

Do work that matters at CSL Behring!