Global Clinical Quality & Compliance Leader

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda seeks a Quality Assurance professional to drive GCP compliance across global clinical research programs, leading audits, and ensuring inspection readiness. You will partner with the Head of Clinical Program Quality to design risk-based strategies and guide investigations while communicating findings to senior stakeholders.

The role requires 7+ years in pharma/biotech QA, ICH GCP knowledge, and strong writing/communication skills. Travel may be required as part of audits and inspections.

Qualifications

• Minimum of 7 years in pharma/biotech with clinical QA experience.
• Extensive knowledge of ICH GCP R2 and global regulations.
• Proven ability to lead audits and develop CAPAs.
• Strong technical writing and communication skills.
• Ability to manage multiple projects with tight timelines.

Responsibilities

• Define and implement risk-based audit strategy for programs.
• Lead pre-approval inspection readiness and manage inspections.
• Escalate critical issues to CPMQ management with recommended actions.
• Collaborate with Quality Compliance to mitigate GCP issues.
• Develop metrics and report program status to leadership.

Skills

GCP compliance

Audit & QA

Project management

Technical writing

Communication

Collaboration

Risk assessment

Education

BS/BA in related field

Advanced degree preferred

Job description

Takeda seeks a Quality Assurance professional to drive GCP compliance across global clinical research programs, leading audits, and ensuring inspection readiness. You will partner with the Head of Clinical Program Quality to design risk-based strategies and guide investigations while communicating findings to senior stakeholders.

The role requires 7+ years in pharma/biotech QA, ICH GCP knowledge, and strong writing/communication skills. Travel may be required as part of audits and inspections.