Remote CQA Lead: Audit Strategy & Team Coaching

Sanofi; New Mexico; Remote; USD 140,000 - 190,000; Full time

Job summary

Sanofi seeks a CQA Team Leader to supervise auditors, drive training and development, and ensure high-quality audit activities across clinical trials. The role focuses on coaching, objectives, and adherence to ICH/GCP, regulatory requirements, and company policies.

Reporting to the Head of Clinical Quality Assessment, you will lead audit planning, risk-based assessments, and collaboration with cross-functional teams.

Qualifications

• Bachelor's degree in Life Sciences, Medical Sciences, Natural Sciences, or a related scientific discipline, or equivalent experience.
• Minimum 10 years of relevant experience with a bachelor's degree, or 5 years of relevant experience with an advanced degree.
• Minimum 5 years of Clinical Quality Assessment experience and/or experience in Clinical Trials, including Monitoring or Clinical Trial Management, with a demonstrated track record of strong performance.
• Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain.
• Good working knowledge of standard computerized software.
• Good business communication skills in English (orally / in riting).
• General management experience with technical / scientific staff
• Demonstrated knowledge in digital transformation and agile methodologies.

Responsibilities

• Oversees day-to-day performance of individuals ensuring appropriate coaching and training on ICH/GCP, relevant regulatory requirements and global, departmental and geographical QDs, policies and guidelines.
• Directly manages his/her team and business support staff, including objectives & performance management, individual development, administrative matters, and hiring as necessary.
• Directly leads and plays a key role in audit planning, actively participates in the development of the annual schedules and regular revisions of audit strategies.
• In collaboration with CQA Management team, contributes to the development, review and updates of the policies, procedures, guidelines and other standards, and ensures their implementation within his/her team.
• Ensures appropriate implementation of planned audits and ensures his/her team resources are put to optimum use for all types of audits assigned, and ensures that skills are developed at team level.
• Responsible for the quality of the audits conducted by his/her team, including adequate conduct, reporting and follow-up of the audit activities as per departmental procedures, guidelines, etc. Ensures a quality driven risk-based approach to audit scope and reviews.
• Ensures the contribution of all members of his/her team to support key customers and provide GCP consultation in relation to audits and inspections, regulation interpretation and input / communication on functional or cross functional procedures.
• Participates in audits as needed with emphasis on complex objectives and/or as part of audit staff coaching, training, and assessment.
• Utilize predictive analytics and real-time data insights to identify potential risks and opportunities associated with clinical trials.
• Leader in determining the needs and designing the associated strategy for assessing audit and inspection quality trends / alerts via Transversal Quality Reviews.
• Under Head of CQA oversight, coordinates and supports the control and follow-up of outsourced / contracted GCP assessment activities.

Skills

Leadership

Auditing

ICH/GCP

Agile

Data analytics

Clinical trials

Education

Bachelor's degree in Life Sciences / related field

Advanced degree (Masters/PhD)

Tools

Standard software knowledge

Job description

Sanofi seeks a CQA Team Leader to supervise auditors, drive training and development, and ensure high-quality audit activities across clinical trials. The role focuses on coaching, objectives, and adherence to ICH/GCP, regulatory requirements, and company policies.

Reporting to the Head of Clinical Quality Assessment, you will lead audit planning, risk-based assessments, and collaboration with cross-functional teams.