Executive Director, R&D – Global Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead a worldwide team dedicated to R&D Quality.

• Ensure OAPI, OPDC, and affiliates are prepared for inspections.

• Supervise support for clinical trials and submissions.

• Direct the R&D audit program.

• Interact with regulatory authorities.

• Uphold the integrity of clinical data.

• Provide vision, guidance, strategic direction, and leadership for R&D Global Quality and the overall Global Quality function.

• Collaborate with business groups and global regions to ensure comprehensive Quality and streamline processes.

• Identify and mitigate Quality risks from development through to commercial registration and product distribution.

• Motivate and nurture Quality professionals while engaging with key stakeholders.

• Ensure that both internal and external sites are prepared for inspections and offer resources during health authority inspections.

• Make sure that findings are properly addressed and that CAPAs are implemented and monitored for effectiveness.

• Analyze findings and evaluate systemic trends.

• Lead audits at clinical facilities, investigator sites, and vendors.

• Set standards and execute quality-management and compliance procedures.

• Report Quality Systems and Risks to Senior Management during Management Review.

• Ensure ongoing inspection readiness across clinical trial sites and in clinical and Pharmacovigilance operations.

• Oversee the planning, execution, and follow-up of both internal and external audits.

• Act as the main liaison with regulatory authorities.

• Ensure the accuracy, consistency, and reliability of clinical and PV data.

• Lead, mentor, and develop QA professionals.

• Work with stakeholders to align QA activities with business and regulatory needs.

• Develop, implement, and maintain policies, systems, and procedures for quality and compliance.

• Direct systems for clinical vendor management and oversight.

• Establish and maintain R&D Management Reviews.

• Develop and manage departmental budgets.

⛳️ Requirements

• Bachelor’s degree and over 15 years of experience in an FDA-regulated pharmaceutical and/or medical device industry setting.

• Extensive knowledge of current global Good Clinical Practice (GCP).

• Up-to-date and thorough understanding of audit techniques and government regulatory inspection procedures.

• Experience and successful interaction with a Japanese company, or a multinational with a Japanese division.

• Previous experience in the global pharmaceutical and medical device sectors.

• Experience working with external service providers.

• Familiarity with current Good Manufacturing Practice (cGMP) regulations.

• Strong project management, leadership, problem-solving, and organizational skills.

• High emotional intelligence.

• Exceptional leadership and team development capabilities.

• Excellent communication and interpersonal skills.

• Ability to collaborate effectively with cross-functional teams.

• Strategic thinking and problem-solving skills.

• Willingness to travel approximately 30% of the time.

🏝️ Benefits

• Incentive opportunity.

• Comprehensive medical coverage.

• Dental coverage.

• Vision coverage.

• Prescription drug coverage.

• Company-provided basic life insurance.

• Accidental death & dismemberment insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.