Job Summary
We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity.

The leader will be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution.

Job Description

• This critical leader will inspire and develop a team of Quality professionals, partner closely with key stakeholders, and assist in the development and delivery of the overall Global Quality (GQ) strategy.
  
   
• This position is responsible for ensuring internal and external sites are inspection ready, resources are provided on site and/or remotely during health authority inspections, observational findings are responded to appropriately and within the required timeframe, and resultant CAPAs are implemented and checked for effectiveness to prevent recurrence. A key deliverable of this role will be analysis of findings and holistic assessment of how the organization can address systemic trends to operate more efficiently and effectively.

• This role will take a leadership position in the conduct of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that audit results are communicated, and appropriate corrective actions are implemented and documented on a timely basis.
  
   
• In addition, this role is responsible for establishing standards and implementing procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting non-compliance and mitigating risks, The performance of the Quality Systems and Risks will be reported periodically to Senior Management through the Management Review process to ensure alignment with Company policy and strategy and gain a consensus of risk mitigation approaches.
  
   

Key Responsibilities:

• Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations.
• Audit Management: Oversee the planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements.
• Regulatory Authority Engagement: Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings.
• Data Integrity: Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes.
• Team Leadership: Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement.
• Stakeholder Partnership: Collaborate with key stakeholders across the organization to align QA activities with business objectives and regulatory requirements.
• Policy Development: Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance.
• Vendor Management: Leads and develops systems for Clinical vendor management and vendor oversight.
• Management Review: Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements.
• Budget Management: Develop and manage the departmental budgets.

Qualifications/ Required

Knowledge/ Experience and Skills:

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment
• Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible. Current and in-depth knowledge of audit techniques and government regulatory inspection procedures
• Strong engagement with the OPCJ business will be required warranting a requirement for experience and successful interaction within a Japanese company, or a multi-national with a Japanese arm.
• Previous experience of working in the global pharmaceutical and medical device industry.
• Experience working with external service providers.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong project management, leadership, problem solving, and organization skills.
• High level of emotional intelligence.
• Exceptional leadership and team development skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively with cross-functional teams.
• Strategic thinking and problem-solving abilities.
• Travel (approximately 30%)