Associate Director, GPV Compliance & Business Management

Associate Director, GPV Compliance & Business Management

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 Associate Director, GPV Compliance & Business Management, supports the development, implementation, and continuous improvement of GPV compliance systems to ensure alignment with global regulatory requirements and internal quality standards. This role leads assigned CBM areas and may coordinate operational activities of vendor partners to maintain strong compliance processes. Key responsibilities include:

• Operational Leadership: Lead assigned CBM functional areas and contribute to broader compliance strategy development in collaboration with Global Quality and internal GPV stakeholders.
• Cross-Functional Collaboration: Work proactively with affiliates, other Otsuka companies, and internal partners to ensure aligned and compliant practices.
• Internal Coordination: Partner with CBM leads to ensure consistent execution across sub-functions.
• Vendor Oversight: Provide oversight of vendor activities within assigned domains. This role may be responsible for managing direct reports.

GPV Due Diligence and Alliance Management Supports the lifecycle relationship with collaborating companies through PV due diligence activities, development and maintenance of Pharmacovigilance Agreements (PVAs), and ongoing compliance oversight. Works cross-functionally across GPV and with internal Otsuka stakeholders to build alignment, promote mutual understanding, and ensure GPVAM processes are integrated appropriately within Global Pharmacovigilance. Partners with GPV and cross-functional leaders to contribute to strategies that support effective and compliant alliance management. Contributes to the harmonization and integration of affiliate companies into GPV processes across functions and regions. Manages day-to-day GPV alliance activities across Otsuka companies and partners, including preparation, coordination, and facilitation of Pharmacovigilance Committee (PVC) meetings. Develops and applies best practices to enhance efficiency and consistency in partner relationship management processes. Ensures adherence to global, local, and regional PV requirements and internal policies/procedures, and supports corrective and preventive actions related to PVAs when needed. Identifies opportunities to support globalization of GPV processes across functional areas, regions, and affiliates through enhanced collaboration and alignment. Facilitates cross-functional and partner-related issue resolution by coordinating discussions, clarifying responsibilities, and ensuring timely follow-through. Oversees assigned team members to support compliance with applicable PV requirements, internal standards, and organizational processes. Provides guidance, training, and support to direct reports and GPV colleagues on integration and alliance-related activities. Serves as a point of contact for GPVAM for assigned alliances during audits and regulatory inspections, supporting evidence gathering and responses. Leads the PV component of CBM due diligence processes for assigned BD projects, focusing on assessment of the target company's PV capabilities. Submits questions through Letters of Query (LoQ), reviews responses, and assesses implications for PV processes and compliance. Reviews relevant materials in data rooms and shared repositories to evaluate PV systems, organizational structure, and potential risks. Identifies and synthesizes key risks, organizational gaps, and challenges and escalates them to PV leadership as appropriate. Contributes to the preparation of structured due diligence reports, ensuring findings are well documented, clearly articulated, and aligned with PV leadership expectations. Supports presentation of PV due diligence outcomes and recommendations to the Business Development (BD) team and other stakeholders.

Additional activities: 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.

Job Scope (Key Facts & Figures):

• 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

Qualifications/Experience Required:

• Bachelor's degree- required
• Experience working in a global setting
• Experience in managing vendor relationships and oversight
• Minimum 4 years PV Compliance or Quality Management experience in the pharmaceutical industry or relevant leadership experience
• Microsoft proficient- Essential

Competencies Required:

• 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 to 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.

Compensation: Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits: 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, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.