Remote CQA Team Leader: Quality & Audit Lead

Sanofi

United States

Remote

USD 134,000 - 193,000

Full time

14 days+
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Benefits offered by this job

Health benefits
Parental leave
Competitive rewards

Job summary

Sanofi is seeking a CQA Team Leader to oversee a group of auditors, drive training and coaching, and ensure quality throughout clinical audits and inspections. You will lead risk-based audit strategies, influence policy updates, and support continuous quality improvements across the department.

The role requires extensive experience in clinical quality, regulatory knowledge, and strong leadership. It offers remote work within the US, with collaboration across global teams and advanced analytical

Qualifications

  • Bachelor's degree in Life Sciences or related field.
  • 10+ years in clinical quality/clinical trials roles with a track record of performance.
  • 5+ years in Clinical Quality Assessment and/or Clinical Trials.
  • Extensive knowledge of international regulations and GCP.
  • Strong business English communication and leadership skills.
  • Experience managing technical staff and driving process improvements.
  • Knowledge of digital transformation and agile methodologies.

Responsibilities

  • Lead strategic risk-based audits and audit planning.
  • Coach and develop auditors; manage objectives, performance and hiring as needed.
  • Collaborate with CQA management to update policies, procedures and standards.
  • Ensure audit quality, timely reporting and follow-up.
  • Apply data analytics to identify risks and opportunities in trials.
  • Support internal/external clients with continuous improvement activities.
  • Lead pre-inspection preparation and post-inspection follow-up activities.

Skills

ICH/GCP knowledge
Auditing leadership
Leadership
English communication
Digital transformation & agile

Education

Bachelor's degree in Life Sciences or related

Tools

Clinical trial management systems
eClinical platforms
Data visualization tools

Job description

Sanofi is seeking a CQA Team Leader to oversee a group of auditors, drive training and coaching, and ensure quality throughout clinical audits and inspections. You will lead risk-based audit strategies, influence policy updates, and support continuous quality improvements across the department.

The role requires extensive experience in clinical quality, regulatory knowledge, and strong leadership. It offers remote work within the US, with collaboration across global teams and advanced analytical

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