Associate Director, R&D Quality Pharmacovigilance Practice

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Good Pharmacovigilance Practice (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 Pharmacovigilance (PV) activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards, procedures and practices. This role offers the opportunity to shape a global GVP QA framework supporting a growing oncology pipeline, with visibility to senior leadership and direct impact on inspection readiness and regulatory success.

• Audit & Inspection Leadership

  • 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

  • Lead, coordinate and support PV inspection readiness activities and contribute to regulatory health authority inspections conduct and management

• Quality Systems & Risk Management

  • Develop/improve and manage quality systems and processes:

• Enhance PV risk-based audit strategy and annual assessment processes in line with regulatory requirements, changing product profile, emerging markets and business dev.

• Responsible for managing/overseeing routine/for cause audits of vendors, partners, processes, affiliate etc.

• Supporting the activities related to the vendor management processes and assessments as well as sub-contractors, etc.

• Maintaining Key QA requirements in line with GVP legislation such as investigations, Quality Events (QEs), Deviations, CAPAs, Findings, Change controls, etc.

• Overseeing and managing Quality Management Risk plans and management reviews

• Conducting/managing review of key PV procedures and documents

• Developing quality KPI’s and metrics and measures to drive assessment and continuous improvement

• Management and review of trends and report significant 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