Associate Director Clinical Program Quality

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Job Description

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.

How you will contribute:

• 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.

In this position you will report to the Head of Clinical Program Quality, Gastrointestinal and Inflammation.

What you bring to Takeda:

• 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.

About Us:

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.

Certified as a Great Place to Work, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$137,000.00 - $215,270.00

The estimated salary r