Remote CQA Team Lead - Quality & Audit Excellence

BioSpace; Home (KS); Remote; USD 120,000 - 160,000; Full time

Job summary

Sanofi in the United States is seeking a CQA Team Leader (Remote) to manage a team of auditors and drive training, coaching, and development. You will support clinical projects through audits, inspections, quality reviews, and GCP guidance, leading improvement initiatives and ensuring compliant processes.

As part of the Clinical Quality Assessment leadership, you will shape audit strategies, allocate resources, and mentor staff while collaborating with global teams and regulatory bodies.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10 years with a bachelor’s or 5 years with an advanced degree.
• 5+ years in Clinical Quality Assessment and/or Clinical Trials.
• Extensive knowledge of international regulations and GCP.
• Strong business English communication skills.
• Experience with digital transformation and agile methods.

Responsibilities

• Oversee day-to-day performance of auditors with coaching and training on ICH/GCP and regulatory requirements.
• Directly manage team objectives, performance and development plus hiring as needed.
• Contribute to annual goals and audit strategy planning and updates.
• Lead audit planning, schedules and revisions of audit strategies.
• Ensure quality of audits, reporting, follow-up per procedures.
• Apply data quality controls and leverage AI for risk-based insights.

Skills

Audit leadership

Quality systems

Regulatory knowledge

GCP knowledge

Project management

Education

Bachelor's degree in Life Sciences

Advanced degree

Tools

CTMS

Data analytics

Job description

Sanofi in the United States is seeking a CQA Team Leader (Remote) to manage a team of auditors and drive training, coaching, and development. You will support clinical projects through audits, inspections, quality reviews, and GCP guidance, leading improvement initiatives and ensuring compliant processes.

As part of the Clinical Quality Assessment leadership, you will shape audit strategies, allocate resources, and mentor staff while collaborating with global teams and regulatory bodies.