Clinical QA Leader: Inspection Readiness & Program Quality

Takeda; United States; On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda seeks a seasoned GCP Quality Assurance professional to oversee quality assurance across global clinical research programs, ensuring inspection readiness for PAI and related activities. You will partner with clinical program teams to deliver risk-based quality guidance and timely investigations.

You will define and implement audit strategies, manage site and vendor audits, escalate critical issues, and support health authority inspections.

Qualifications

• BS/BA required; Advanced Degree preferred.
• Minimum of 7 years in pharma/biotech industry.
• Minimum 5 years of GCP QA or clinical trial experience.
• Extensive knowledge of ICH GCP R2 and global regulations.
• Auditing skills and ability to translate findings into corrective actions.
• Strong communication and matrix leadership abilities.
• Attention to detail and ability to analyze complex data.

Responsibilities

• Provide GCP compliance expertise to program teams and leadership.
• Develop risk-based audit and compliance strategies; manage audits.
• Assess impact of findings on safety, data integrity, and operations.
• Ensure timely audit reports and corrective actions.
• Facilitate investigations and corrective actions; track effectiveness.
• Support GCP health authority inspections and prepare responses.
• Collaborate to identify and mitigate GCP issues across sites.
• Analyze metrics and present to CPMQ management.
• Escalate systemic problems; propose solutions.
• Perform additional GCP activities as needed.

Skills

GCP Quality Assurance

Auditing

Regulatory knowledge

Quality reporting

Risk management

Communication

Project management

Education

BS/BA in life sciences

Advanced degree

Tools

Audit tracking systems

Regulatory databases

Job description

Takeda seeks a seasoned GCP Quality Assurance professional to oversee quality assurance across global clinical research programs, ensuring inspection readiness for PAI and related activities. You will partner with clinical program teams to deliver risk-based quality guidance and timely investigations.

You will define and implement audit strategies, manage site and vendor audits, escalate critical issues, and support health authority inspections.