Associate Director, R&D Quality Good Pharmacovigilance Practice

BeOne Medicines Ltd.; California; On-site; USD 150,000 - 230,000; Full time

Job summary

BeOne Medicines Ltd. seeks a GVP Quality Lead to implement and maintain a proactive global PV QA framework supporting an oncology pipeline. You will influence senior leadership and ensure PV activities meet regulatory standards across development stages.

The role emphasizes QA system development, vendor oversight, risk management, and inspection readiness, with travel as needed. A strong background in GVP/GCP and global regulations is essential.

Qualifications

• Bachelor degree and 8+ years of Pharmacovigilance experience.
• Master's degree and 6+ years of related experience preferred.
• Expert global knowledge of GVPs and GCP requirements.
• Understanding of international regulations for clinical trials and pharmacovigilance operations.
• Ability to lead in a matrixed global organization and drive improvements.
• Promote continuous improvements in quality systems and department infrastructure.

Responsibilities

• Audit & Inspection Leadership for PV QA activities and inspections.
• Lead PV inspection readiness activities and support regulatory inspections.
• Develop and manageQuality Systems and risk management processes.
• Oversee vendor management and subcontractor QA activities.
• Develop quality KPIs and metrics and drive continuous improvement.
• Coordinate GCP/GVP training and knowledge sharing.
• Collaborate with Global Patient Safety, Regulatory Affairs, Medical, and Clinical operations to ensure PV requirements are met.

Skills

Leadership

Attention to detail

Multitasking

Cross-functional collaboration

Education

Bachelor of Science

Master's degree

Tools

Veeva

SumTotal

Smartsheet

ACE Audit Utopia

Job description

General Description:

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.

Essential Functions of the job:

• 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
• Vendor Oversight
  • Strong global knowledge and understanding of international PV regulations applicable to the conduct of clinical trials and pharmacovigilance operations
• Metrics & Continuous Improvement
  • 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
• Cross-functional Leadership
  • 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

Education and Experience Required:

• Bachelor of Science degree and 8+ years of Pharmacovigilance experience required
• Master's degree and 6+ years of related experience preferred
• 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

Computer Skills:

Microsoft 365, Veeva, SumTotal, ACE Audit utopia, Smartsheet

Other Qualifications:

• Budgeting and finance skills Auditor certification a plus
• Quality System certification a plus

Travel:

30% travel may be required

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.