Associate Director, R&D Quality Good Pharmacovigilance Practice

BeiGene

66d•$143,400 - $193,400•Remote

About The Position

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.

Requirements

Bachelor of Science degree and 8+ years of Pharmacovigilance experience required
Expert global knowledge of GVPs and GCP requirements
Understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operation
Able to lead in a matrixed global organization, people and process, support with reviews and day to day tasks
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
Microsoft 365, Veeva, SumTotal, ACE Audit utopia, Smartsheet

Nice To Haves

Master’s degree and 6+ years of related experience preferred
Budgeting and finance skills
Auditor certification a plus
Quality System certification a plus

Responsibilities

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
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
Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations
Keep up to date with knowledge of GVP requirements and implement them in GVP QA procedures and day to day tasks
Develop tools and assessment improvements using AI to increase efficiency in routine processes
Participate and support as backup to the Head, GVP QA to enhance performance and maintain accountability for the implementation of BeOne QA systems
Coordinate / cooperate with interfacing departments such as Global Patient Safety, Regulatory Affairs, Medical affairs, Clinical operations, Quality to ensure implementation of PV 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
Participate and represent R&D Quality in meetings and discussions