Director, Clinical Quality & Program Excellence

Takeda Pharmaceutical Company Limited; Boston (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda Pharmaceutical Company Limited is seeking a Director, CPQE to lead quality oversight across clinical programs in Boston. You will drive risk-based strategies, ensure inspection readiness, and partner with global teams to safeguard patient safety, integrity, and regulatory submissions.

Responsibilities include directing quality programs, leading investigations, and shaping governance with senior stakeholders while fostering a culture of continuous improvement and quality by design.

Qualifications

• Bachelor's degree in a scientific, medical, healthcare, or related discipline.
• Minimum 10 years of pharmaceutical/biotech/healthcare experience.
• At least 5 years in Quality, Compliance, Clinical Development Quality, or related functions.
• Deep knowledge of GCP, quality systems, and clinical trial processes.
• Experience supporting global development programs from start-up to submission.
• Proven ability to lead oversight, inspection readiness, audits, and compliance initiatives.

Responsibilities

• Lead quality management activities for assigned clinical programs with risk-based oversight.
• Serve as strategic quality advisor to governance bodies and cross-functional teams.
• Identify, escalate, and mitigate quality risks to support patient-centric decisions.
• Lead investigations into quality events, breaches, and deviations.
• Develop inspection readiness strategies and regulatory interaction readiness.
• Drive global GCP inspection planning and participate in inspections.

Skills

GCP knowledge

Quality systems

Global program support

Investigation/root cause analysis

Stakeholder influence

Communication skills

Leadership

Education

Bachelor's degree in a scientific field

Job description

Takeda Pharmaceutical Company Limited is seeking a Director, CPQE to lead quality oversight across clinical programs in Boston. You will drive risk-based strategies, ensure inspection readiness, and partner with global teams to safeguard patient safety, integrity, and regulatory submissions.

Responsibilities include directing quality programs, leading investigations, and shaping governance with senior stakeholders while fostering a culture of continuous improvement and quality by design.