Associate Director Clinical Program Quality

Takeda

2d • Remote

About The Position

Are you looking for a patient-oriented, innovation-driven role that inspires you and promotes your career? Then take your future in your hands and become part of our team as a Associate Director Clinical Program Quality This role combines global strategic influence with meaningful impact on patient safety, data integrity, and the successful delivery of complex clinical programs across multiple therapeutic areas. It offers you a unique opportunity to lead high-visibility inspections, shape risk-based quality strategy, solve complex challenges, and act as a trusted advisor to senior stakeholders while driving continuous improvement across the organization.

Requirements

• Bachelor’s degree required.
• At least 10 years of experience in the pharmaceutical, biotechnology, or related healthcare industry.
• At least 7 years of GCP-related Quality Assurance or relevant clinical trial experience.
• Strong knowledge of ICH GCP and applicable global clinical development regulations and guidance.
• Advanced expertise in planning, conducting, and reporting audits, including translating findings into effective corrective action plans.
• Excellent communication, stakeholder management, negotiation, and influencing skills in a matrix environment.
• Strong judgment, project management, critical thinking, and analytical skills, with the ability to manage complex issues and multiple priorities.

Responsibilities

• Provide quality assurance oversight for global clinical research programs to ensure ongoing inspection readiness.
• Serve as a strategic quality partner to Clinical Program Teams and key stakeholders, offering risk-based GCP quality and compliance advice.
• Define and implement program-specific, risk-based audit and compliance strategies across studies, sites, vendors, documents, databases, and internal systems.
• Lead pre-approval and health authority inspection readiness, manage inspections, coordinate responses, follow-up actions, and risk mitigation.
• Lead investigations into major quality issues, serious GCP breaches, and scientific misconduct, including root cause analysis and CAPA development.
• Monitor, analyze, and present quality and compliance metrics, escalating critical or systemic risks to management and recommending corrective actions.
• Support organizational quality excellence through mentoring, cross-functional collaboration, due diligence, and process improvement initiatives.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level