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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 may shift based on business needs or direction from leadership. The Director, GPV Compliance & Business Management, leads the execution of the strategic direction of internal GPV compliance systems, aligning with global regulatory guidelines and standards. The role leads a team of internal colleagues and manages a vendor team to deliver and maintain robust compliance frameworks across the GPV organization.

• Define and implement the compliance strategy for GPV functional areas in collaboration with Global Quality Management (GQM) and functional internal stakeholder feedback across GPV.
• Partner globally with affiliates, other Otsuka companies, external pharmaceutical organizations, and internal teams (Regulatory Affairs, Clinical Management, etc.) to ensure consistent compliance practices.
• Work closely with other CBM leads and colleagues to coordinate activities across CBM sub-functions and maintain a unified approach to compliance.
• Provide leadership and oversight of the external vendor supporting GPV compliance activities, ensuring performance, quality, and regulatory alignment.
• Lead complex projects or programs of strategic importance involving cross‑functional teams.
• Implement strategic goals determined by executive leaders, with direct impact on department or functional area results.
• May be responsible for managing direct reports.

• Provide strategic leadership and oversight of global Pharmacovigilance 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 and driving resolution through to closure.
• Oversee planning, resourcing, and strategic coordination of Global Quality audits affecting affiliates for PV, global PV processes, and alliance company activities.
• Lead the governance of alliance company and Global Service Provider PV audit activities.
• Serve as a senior liaison with Inspectorates, Regulatory Agencies, industry associations, and inter‑company networks to anticipate regulatory trends and benchmark PV inspection practices.
• Provide strategic direction and escalation support to Local Safety Managers across all PV‑related audit and inspection activities.
• Drive global readiness, strategic planning, and post‑inspection remediation for GPV audits and inspections.
• Oversee the audit and inspection governance framework for key collaborating companies.
• Provide strategic oversight for the development and delivery of departmental training programs that strengthen inspection readiness.
• Lead enterprise‑wide initiatives to optimize PV processes for reliability, effectiveness, and operational efficiency.
• Oversee and guide root cause analysis and investigations into non‑adherence to PV requirements.

• Provide strategic leadership and oversight across Otsuka GPV functions to ensure effective development, prioritization, and governance of PV‑related CAPAs resulting from internal quality audits and regulatory inspections.
• Lead and guide CAPA owners through complex investigations, ensuring rigorous root‑cause analysis and timely high‑quality CAPA closure.
• Partner at a senior level with Global Quality to ensure globally aligned, timely, and regulatory‑compliant audit and inspection responses.
• Oversee and accelerate the closure of PV‑related CAPAs and audit findings—internal and external—ensuring strategic remediation and sustainable quality improvements.
• Provide executive oversight of PV‑related CAPA development, management, and metrics tracking.
• Review and approve PV‑related CAPA records at key stages of the lifecycle.
• Oversee governance, prioritization, and cross‑functional coordination of PV‑related Deviations, TCCs, and Standalone CAPAs.
• Lead regular governance meetings with Global Quality to drive cross‑functional alignment and proactive PV quality culture.

• Accountable and principal expert contributor for performing defined cross‑pillar activities aligned to the key responsibilities of the other Compliance and Business Management pillars.
• Provide strategic direction, oversight, and subject‑matter expertise to ensure activities are executed within other pillars as defined by global compliance, regulatory requirements, and policies/procedures.
• Attend Global / Regional meetings as required; present compliance metrics at Global Meetings.
• Contribute to maintenance of PV System Master File as required.
• May be assigned to lead or assist with special projects or process development.
• Collaborate with the Regional PV offices for process improvement initiatives and corrective and preventive actions identified by the Regional PV offices.
• May perform any other duties as needed.

• Travel as applicable.
• Knowledge of ICH, US & EU regulations and requirements for pharmacovigilance.
• Solid background and experience in pharmaceutical quality system management (GxP).
• Experience with coordination and/or participation in PV audits in the pharmaceutical industry.
• Strong project management, interpersonal, communication and presentation skills.
• Ability to accomplish objectives through influence in a matrix organization.
• Strong computer skills with Word, Excel, PowerPoint, and Outlook.

• 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.

• Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving – Make decisions considering the long‑term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity – Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication – Communicate with logic, clarity, and respect.
• Influence at all levels – Achieve the best results for Otsuka.
• Respectful Collaboration – Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development – Play an active role in professional development as a business imperative.

Comprehensive medical, dental, vision, prescription drug coverage, company‑provided basic life, accidental death & dismemberment, short‑term and long‑term disability insurance, tuition reimbursement, student loan assistance, generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company‑provided benefits.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation. You can request reasonable accommodations by contacting Accommodation Request.