Executive Director, R&D Global Quality

Remote

Full time

R12983

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.

• 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.

• 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,…