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 within the CBM team are interchangeable and may shift based on business needs or direction from leadership.

The Director, GPV Compliance & Business Management, is responsible for leading the execution of the strategic direction of internal GPV compliance systems to ensure alignment with global regulatory guidelines and standards. This role leads a team of internal colleagues and manages a vendor team to deliver and maintain robust compliance frameworks across the GPV organization.

Key responsibilities include:

• 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.

This is a global role with broad scope and impact requiring strong leadership, strategic thinking, and collaborative execution such as:

• Principal expert contributor and organizational thought leader for discipline
• Leads complex projects or programs of strategic importance, involving cross‑functional teams
• Implements strategic goals, as determined by executive leaders, with direct impact on department or functional area results

This role may be responsible for managing direct reports.

The PV Quality Assurance Lead manages GPV CAPA and deviation processes, supports audit and inspection readiness, and ensures PV quality system compliance. The role partners across functions to resolve issues, improve processes, and maintain high standards of quality and regulatory adherence.

• Provide strategic leadership and oversight of Global Pharmacovigilance (GPV) audit and inspection preparedness, ensuring a state of continuous readiness across all regions in partnership with Local Safety Managers and key global stakeholders.
• Direct the global strategy, governance, and execution of GxP regulatory inspections impacting PV, ensuring alignment with Global Quality and driving resolution through to closure with a strong focus on regulatory excellence.
• Oversee the planning, resourcing, and strategic coordination of Global Quality audits affecting affiliates for PV, global PV processes, and alliance company activities, ensuring effective global support and timely audit closure.
• Lead the governance of alliance company and Global Service Provider PV audit activities, ensuring compliance with contractual obligations, performance expectations, and global PV quality standards.
• Serve as a senior liaison with Inspectorates, Regulatory Agencies, industry associations, and inter-company networks to anticipate regulatory trends, benchmark PV inspection practices, and influence best practices.
• Provide strategic direction and escalation support to Local Safety Managers (LSMs) across all PV-related audit and inspection activities to ensure consistent global compliance.
• Drive global readiness, strategic planning, and post-inspection remediation for GPV audits and inspections, ensuring oversight of CAPA development, implementation, and long‑term mitigation strategies.
• Oversee the audit and inspection governance framework for key collaborating companies,…