Director, GPV Compliance & Business Management (QA)

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 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.

Key responsibilities include:

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.

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 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, ensuring adherence to compliance expectations, risk mitigation, and ongoing quality performance management.
• Provide strategic oversight for the development and delivery of departmental training programs that strengthen inspection readiness, advance PV quality culture, and support continuous improvement initiatives.
• Lead enterprise-wide initiatives to optimize PV processes for reliability, effectiveness, and operational efficiency, driving continuous improvement and innovation.
• Oversee and guide root cause analysis and investigations into non-adherence to PV requirements, ensuring strategic risk mitigation, sustainable corrective actions, and systemic prevention.

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 resulting from internal quality audits and regulatory inspections.
• Lead and guide CAPA owners through complex investigations, ensuring rigorous root?cause analysis, impact assessment, and timely, high?quality PV-related CAPA closure.
• Partner at a senior level with Global Quality to ensure globally aligned, timely, and regulatory?compliant audit and inspection responses, while driving clear accountability and ownership among PV SMEs worldwide.
• Oversee and accelerate the closure of PV-related CAPAs and audit findingsinternal and externalensuring strategic remediation, risk mitigation, and sustainable quality improvements across the PV system.
• Provide executive oversight of PV?related CAPA development, management, and metrics tracking, including evaluation of audit/inspection findings to identify systemic trends and opportunities for improvement.
• Review and approve PV-related CAPA records at key stages of the lifecycle to ensure compliance with global procedures, adequacy of documentation, and alignment with regulatory expectations.
• Oversee the governance, prioritization, and cross?functional coordination of PV?related Deviations, Temporary Change Controls (TCCs), and Standalone CAPAs, ensuring robust quality and compliance controls.
• Lead regular governance meetings with Global Quality, establishing best practices, driving cross?functional alignment, managing escalations, and ensuring a proactive and inspection?ready PV quality culture.

Secondary Responsibilities Cross Pillar:

• In addition to pillar?specific responsibilities, the Director is accountable and a principle expert contributor for performing defined cross?pillar activities aligned to the key responsibilities of the other Compliance and Business Management pillars (Contract Compliance Management; Due Diligence and Alliance Management; Compliance Assurance).
• The Director provides strategic direction, oversight, and subject?matter expertise to ensure that activities are executed within other pillars as defined by global compliance, regulatory requirements, and policies/procedures.

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 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

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.

Competencies:

Accountability for Results - Stay focused on key strategic objectives