Director, GPV Compliance & Business Management (QA)
Position Summary
The Compliance & Business Management (CBM) team supports key Pharmacovigilance (PV) operational, compliance, and business activities across the organization. This role ensures PV compliance, supports contract management, facilitates audit and inspection readiness, manages CAPA and deviation processes, and contributes to metrics reporting, alliance management, training, SOP governance, and documentation quality.
Responsibilities
Strategic Leadership: Define and implement the compliance strategy for GPV functional areas in collaboration with Global Quality Management (GQM) and functional internal stakeholder feedback across GPV.
Cross-Functional Collaboration: Partner globally with affiliates, other Otsuka companies, and external pharmaceutical organizations, as well as internal teams such as Regulatory Affairs, Clinical Management, etc. to ensure consistent compliance practices.
Internal Alignment: Work closely with other CBM leads and colleagues to coordinate activities across CBM sub-functions and maintain a unified approach to compliance.
Vendor Oversight: Provide leadership and oversight of the external vendor supporting GPV compliance activities, ensuring performance, quality, and regulatory alignment.
Key Responsibilities
PV Quality Assurance Lead: Manage GPV CAPA and deviation processes, support audit and inspection readiness, and ensure PV quality system compliance.
Global PV Audit and Inspection Readiness Lead: Provide strategic leadership and oversight of Global Pharmacovigilance (GPV) audit and inspection preparedness, ensuring a state of continuous readiness across all regions.
Global PV CAPA & Deviation Management Lead: Provide strategic leadership and oversight across Otsuka GPV functions to ensure the effective development, prioritization, and governance of PV-related CAPAs.
Qualifications/Experience Required
Bachelor's degree- required
Experience working in a global setting
Experience in managing vendor relationships and oversight
Minimum 6 years PV Compliance or Quality Management experience in the pharmaceutical industry or relevant leadership experience
Microsoft proficient- Essential
Experience with GVP, GCP, inspections conducted by FDA, MHRA, etc.
Experience with quality compliance management systems