Head Of Glp/Gclp Quality (Eu)

Stellenbeschreibung

For our Functional Unit GLP/GCLP Quality & Early Development Process Controls R&D Quality in Marburg we are looking for a

Head of GLP/GCLP Quality (EU) (f/m/d) - R-192816

(fulltime/ permanent/ level 7/ location: Marburg)

Position Purpose

• Drive the implementation of GLP and GCLP quality Initiatives, Systems, Processes and Quality Operations within R&D for APAC

• Be a key driver in the development of GLP and GCLP phase appropriate quality strategies during the Research, Pre-Clinical and Clinical Phases of Product Development

• Implement defined Quality Systems for GLP/GCLP and execute audits for EU R&D

• Develop and execute inspection readiness activities in the GLP/GCLP space

• Ensuring regulatory compliance to GLP, GCLP (ISO17025), GRLP and other GxP requirements (as applicable)

• 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

Main Responsibilities and Accountabilities:

• Implement and manage GLP/GCLP QS for EU ensuring policies and procedures are in line with Global R&D Quality.

• Track and trend R&D Quality Key Performance Indicators 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 programs; ensuring consistency across programs and regions

• Primary representative for R&D Quality on site quality management forums and discussions (EU)

• Maintain phase appropriate Quality Systems for GLP/GCLP

• Primary EU representative for GLP/GCLP for Change Control Panel (as required)

• 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 are in compliance with applicable regulatory requirements, relevant industry standards and company policies and SOPs.

• Support the vendor audit programme for GLP/GCLP by performing audits in the EU as required.

• Support R&D Research with change and deviation management for GCLP (ISO 17025)

• Facilitate GxP assessments for R&D equipment and facilities

• Support the GLP quality assurance programme by executing audits for Research and Clinical Bioanalytics and Global Pathogen Safety

• Develop EU GLP/GCLP (inc. GRLP) internal audit schedule for R&D Research functional areas and R&D Product Development functional areas

• Plan and conduct EU GLP (inc. GRLP) internal audits according to the OECD Principles of GLP to support continued recognition for R&D Research and R&D Product Development functional areas covering,

• Facility inspections;

• Process inspections;

• Study inspections;

• Document inspections

• Plan and conduct EU ISO/IEC 17025 internal audits according to the general requirements for the competence of testing and calibration laboratories internal audits for R&D Research functional areas and R&D Product Development functional areas covering,

• General requirements

• Structural requirements

• Resource requirements

• Process requirements

• Management requirements

• Assist with the development of global Quality Management Review for GLP/GCLP and Early Development Process control stream

• Ensure all audit findings are reported to Test/Site Facility Management and Study Director and Principal Investigator as applicable for:

• R&D Research (Research and Clinical Bioanalytics) MBR

• R&D Product Development (Global Pathogen Safety) MBR

• Host external GLP and GCLP (ISO/IEC 17025) regulatory audits

• Track and trend audit finding responses for GLP and GCLP (ISO/IEC 17025) regulatory audits

• Develop and build strong business relationships with local and global R&D Quality sites to ensure alignment with 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

Position Qualifications and Experience Requirements

• University degree (BSc, MSc, PhD) in relevant biological science

• Minimum of 7 years’ experience in one of the following: R&D Quality (GMP or GLP) and/or product development team

• Expertise in GLP

Our Benefits

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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.

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