Associate Director, R&D Quality Good Pharmacovigilance Practice

Auditing & Inspection Leadership

Conduct and support Quality Assurance (QA) activities related to applicable Pharmacovigilance (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 development.
• Manage/oversee 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.
• Maintain Key QA requirements in line with GVP legislation such as investigations, Quality Events (QEs), Deviations, CAPAs, Findings, Change controls, etc.
• Oversee and manage Quality Management Risk plans and management reviews.
• Conduct/manage review of key PV procedures and documents.
• Develop quality KPI’s and metrics and measures to drive assessment and continuous improvement.
• 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 & Experience

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

Other Qualifications

• Computer Skills: Microsoft 365, Veeva, SumTotal, ACE Audit utopia, Smartsheet.

Global Competencies

• Fosters Teamwork
• Solicits Honest and Actionable Feedback
• Self-Awareness
• Demonstrates Inclusivity
• Acts with Initiative
• Has Entrepreneurial Mindset
• Continuously Learns
• Adapts to Change
• Focuses on Results
• Uses Analytical Thinking/Data Analysis
• Exhibits Financial Excellence
• Communicates with Clarity

Pay & Benefits

Salary Range: $143,400.00 - $193,400.00 annually

Benefits:

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Additional:

• Annual bonus plan for non-commercial roles
• Incentive compensation plan for commercial roles
• Discretionary equity awards
• Voluntary participation in the Employee Stock Purchase Plan