Director, GPV Compliance & Business Management (QA)

This role within the Compliance & Business Management (CBM) team supports key Pharmacovigilance (PV) operational, compliance, and business activities across the organization. It 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 may shift based on business needs or leadership direction.

About the role

The Director, GPV Compliance & Business Management, leads 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.

Responsibilities

• Strategic Leadership: Define and implement the compliance strategy for GPV functional areas in collaboration with Global Quality Management (GQM) and internal stakeholders.
• Cross-Functional Collaboration: Partner globally with affiliates, other Otsuka companies, external pharmaceutical organizations, and internal teams such as Regulatory Affairs and Clinical Management to ensure consistent compliance practices.
• Internal Alignment: Work closely with other CBM leads to coordinate activities across sub-functions and maintain a unified compliance approach.
• Vendor Oversight: Provide leadership and oversight of external vendors supporting GPV compliance activities, ensuring performance, quality, and regulatory alignment.
• Global PV Audit and Inspection Readiness Lead:
  • Provide strategic leadership and oversight of Global Pharmacovigilance (GPV) audit and inspection preparedness, ensuring continuous readiness across all regions.
  • Direct the global strategy, governance, and execution of GxP regulatory inspections impacting PV, ensuring alignment with Global Quality.
  • Oversee planning, resourcing, and coordination of Global Quality audits affecting affiliates, global PV processes, and alliance company activities.
  • Lead governance of alliance company and Global Service Provider PV audit activities, ensuring compliance with contractual obligations and global PV quality standards.
  • Serve as a senior liaison with regulatory agencies, industry associations, and inter-company networks to anticipate trends and influence best practices.
  • Provide strategic direction and escalation support to Local Safety Managers for PV-related audit and inspection activities.
  • Drive global readiness, strategic planning, and post-inspection remediation, including CAPA oversight and long-term mitigation strategies.
  • Oversee the audit and inspection governance framework for collaborating companies, ensuring compliance and risk mitigation.
  • Provide strategic oversight for departmental training programs to strengthen inspection readiness and PV quality culture.
  • Lead initiatives to optimize PV processes for reliability, effectiveness, and operational efficiency.
  • Guide root cause analysis and investigations into non-adherence to PV requirements, ensuring risk mitigation and sustainable corrective actions.
• Global PV CAPA & Deviation Management Lead:
  • Provide strategic leadership for PV-related CAPAs from internal audits and regulatory inspections.
  • Lead and guide CAPA owners through complex investigations, ensuring rigorous root-cause analysis and timely closure.
  • Partner with Global Quality to ensure globally aligned, regulatory-compliant audit and inspection responses.
  • Oversee and accelerate closure of PV-related CAPAs and audit findings, ensuring strategic remediation and risk mitigation.
  • Provide executive oversight of CAPA development, management, and metrics tracking to identify systemic trends.
  • Review and approve PV-related CAPA records for compliance and alignment with regulatory expectations.
  • Oversee governance, prioritization, and coordination of PV-related Deviations, Temporary Change Controls (TCCs), and Standalone CAPAs.
  • Lead governance meetings with Global Quality to establish best practices and drive cross-functional alignment.
• Cross-Pillar Responsibilities:
  • Serve as a principal expert contributor for cross-pillar activities within Compliance and Business Management (Contract Compliance Management; Due Diligence and Alliance Management; Compliance Assurance).
  • Provide strategic direction, oversight, and subject-matter expertise for activities in other pillars.
  • Attend global/regional meetings and present compliance metrics as required.
  • Contribute to the maintenance of the PV System Master File.
  • Lead or assist with special projects or process development initiatives.
  • Collaborate with Regional PV offices for process improvement and corrective actions.

Requirements

• Bachelor’s degree (required).
• Minimum 6 years of PV Compliance or Quality Management experience in the pharmaceutical industry or relevant leadership experience.
• Experience working in a global setting.
• Experience managing vendor relationships and oversight.
• Knowledge of ICH, US, and EU regulations for pharmacovigilance.
• Solid background in pharmaceutical quality system management (GxP).
• Experience with coordination and/or participation in PV audits.
• Experience with GVP, GCP, and inspections conducted by FDA, MHRA, etc.
• Proficiency with quality compliance management systems.
• Strong project management, interpersonal, communication, and presentation skills.
• Ability to accomplish objectives through influence in a matrix organization.
• Strong computer skills (Word, Excel, PowerPoint, Outlook).

Skills

• Accountability for Results: Focus on strategic objectives, maintain high performance standards, and lead change.
• Strategic Thinking & Problem Solving: Make decisions considering long-term impact on customers, patients, employees, and the business.
• Patient & Customer Centricity: Maintain focus on the needs of customers and stakeholders.
• Impactful Communication: Communicate with logic, clarity, and respect to influence at all levels.
• Respectful Collaboration: Seek and value diverse perspectives to enhance partnerships.
• Empowered Development: Actively engage in professional development as a business imperative.

Pay

Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity. The range represents typical pay for individuals hired in the U.S., with actual pay determined by experience, skills, and internal comparisons.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company-provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Additional company-provided benefits.