Associate Director - GVP Quality Lead EMEA

Associate Director - GVP Quality Lead EMEA

BeiGene

Basel, Switzerland

General Description:

The GVP Quality Lead, is responsible for supporting the Director GVP Quality in implementing and maintaining a balanced, proactive, global approach to GVP Quality Assurance. This position will be primarily responsible for ensuring PV activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards, procedures and practices.

Essential Functions of the job:

• Conduct and support quality assurance (QA) activities related to applicable PV regulatory requirements, guidelines, laws and internally established standards, procedures and practices for all phases of drug development;
• Participate and support as member of the GVP QA team to enhance performance and maintain accountability for the implementation of QA systems;
• Develop/improve and manage quality systems and processes to include;
• Conducting/managing routine/for cause audit of vendors, partner, internal audits etc.;
• Supporting the activities related to the vendor management process training, SOPs, etc.;
• Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits;
• Developing and managing Integrated Quality Management Risk plans;
• Conducting/managing review of key PV documents;
• Developing quality metrics and measures to drive assessment and continuous improvement;
• Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate;
• Coordinate and/or administer GCP/GVP training, as needed;
• Participate in the review of metrics (i.e. deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements;
• Coordinate and support PV inspection readiness activities and contribute to regulatory health authority inspections conduct and management;
• Expert knowledge of GVP requirements;
• Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment;
• Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance;
• Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations;
• Participate and represent R&D Quality in meetings and discussions, as needed;
• Other duties as assigned.

Qualifications:

• Bachelor’s degree, preferably in Science;
• Expert knowledge of GVPs and GCP requirements;
• Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors;
• Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate SOPs;
• Proven ability in driving quality process improvement initiatives;
• Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations;
• Excellent English oral & written.

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