Remote CQA Lead — Audits & Quality Strategy

Sanofi; Morristown (NJ); Hybrid; USD 134,000 - 193,000; Full time

Job summary

Sanofi US is seeking a CQA Team Leader to remotely manage a team of auditors in the US, coaching staff and ensuring audits meet ICH/GCP standards and regulatory requirements.

You will lead audit planning, drive inspection readiness, and use data insights and AI-enabled tools to improve quality. This role reports to the Head of Clinical Quality Assessment and offers global impact within clinical trials.

Qualifications

• Bachelor's degree in Life Sciences, Medical Sciences, Natural Sciences, or related field, or equivalent experience.
• Minimum 10 years of relevant experience with a bachelor's degree, or 5 years with an advanced degree.
• Minimum 5 years of Clinical Quality Assessment experience in Clinical Trials, including Monitoring or TM, with strong performance.
• Extensive knowledge of international regulations and GxP pertaining to clinical domain.

Responsibilities

• Oversee day-to-day performance of auditors with coaching and training on ICH/GCP and regulatory requirements.
• Lead audit planning, schedules, and development of audit strategies.
• Ensure quality audits, reporting, and follow-up per procedures.
• Provide GCP consultation and support for inspections and regulatory interactions.
• Coordinate outsourcing activities and support inspection readiness.

Skills

Leadership

Auditing

GCP knowledge

ICH/GCP

Data analytics

AI/digital tools

Team coaching

Communication

Education

Bachelor's degree in Life Sciences or related

Tools

CTMS

eClinical platforms

Data visualization tools

Job description

Sanofi US is seeking a CQA Team Leader to remotely manage a team of auditors in the US, coaching staff and ensuring audits meet ICH/GCP standards and regulatory requirements.

You will lead audit planning, drive inspection readiness, and use data insights and AI-enabled tools to improve quality. This role reports to the Head of Clinical Quality Assessment and offers global impact within clinical trials.