As the Compliance Head for U.S. FDA at Sanofi, you will spearhead efforts to ensure inspection readiness and compliance with regulatory standards across various sites. Your role is pivotal in shaping the company's quality management systems and driving continuous improvement in GMP compliance.
Key Responsibilities
Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up
Enhance inspection readiness through on-site quality system assessments, audits, and gap identification
Oversee FDA inspection preparation, guidance, training, and coaching
Provide direct support to US FDA GMP inspections on-site
Coordinate and prepare briefing materials for US FDA inspections
Maintain oversight of Sanofi’s aggregate GMP US FDA findings and action plans
Lead cGMP compliance projects aligned with the company’s Quality Operations strategy
Drive digital transformation initiatives
Represent Sanofi externally at key industrial and trade association meetings
Required Qualifications
Master’s degree in science, pharmacy, engineering, data science, or equivalent
Current or recent employment at US FDA (within last 3 years)
US FDA experience (>10 years)
Minimum of 15 years relevant experience in pharmaceutical, biotech, medical device, or related industries
Extensive knowledge of Quality Systems and Data Integrity
Strong command of manufacturing processes, validation principles, risk assessment methodologies, and statistical techniques
Minimum of eight years of professional experience as an auditor and/or inspector
Previous experience interfacing with Regulatory Authority Inspectors from different regions