Senior Clinical Quality & Program Integrity Lead

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an experienced QA leader to oversee global clinical research quality programs across multiple units, ensuring inspection readiness and risk-based audit strategy. You will partner with clinical teams, lead pre-approval inspection activities, and manage investigations with timely follow-up.

The role requires a BA/BS with 10+ years in pharma/biotech, strong GCP knowledge, audit leadership, and excellent writing and collaboration skills. Some travel will be needed.

Qualifications

• BA/BS degree required; advanced degree preferred.
• Minimum 10 years in pharma/biotech with GCP QA experience.
• Strong knowledge of ICH GCP and global regulations.

Responsibilities

• Provide GCP QA expertise, audit strategy, and risk mitigation.
• Lead audits of sites, trials, vendors, and systems in compliance with GCP.
• Lead investigations and corrective actions; communicate findings to management.
• Support inspection readiness for GCP health authority inspections.

Skills

GCP knowledge

Auditing

Technical writing

Communication

Project management

Stakeholder management

Education

Bachelor's degree

Advanced degree preferred

Job description

Takeda is seeking an experienced QA leader to oversee global clinical research quality programs across multiple units, ensuring inspection readiness and risk-based audit strategy. You will partner with clinical teams, lead pre-approval inspection activities, and manage investigations with timely follow-up.

The role requires a BA/BS with 10+ years in pharma/biotech, strong GCP knowledge, audit leadership, and excellent writing and collaboration skills. Some travel will be needed.