Design and lead sterility assurance and microbiology programs, ensuring full compliance with regulatory requirements (GMP, Annex 1, FDA, Pharmacopoeia) and company quality standards
Job Summary
Design and lead sterility assurance and microbiology programs, ensuring full compliance with regulatory requirements (GMP, Annex 1, FDA, Pharmacopoeia) and company quality standards.
Lead, coach, and develop a team of experts, fostering a strong culture of quality and operational excellence with regular field presence (~25% of time).
Represent Sanofi during regulatory inspections and audits, and maintain active exchanges with external bodies and communities of practice to stay at the forefront of industry best practices.
Matching Summary
Design and lead sterility assurance and microbiology programs, ensuring full compliance with regulatory requirements (GMP, Annex 1, FDA, Pharmacopoeia) and company quality standards.
Skills & Requirements
Must-have
sterility assurance and microbiology expertise
GMP, Annex 1, FDA, Pharmacopoeia compliance
sterile manufacturing processes
aseptic processing and environmental monitoring
microbiological risk management
leadership and team development
Nice-to-have
patient safety focus
continuous improvement initiatives
collaboration with digital and technical teams
regulatory inspection representation
cross-functional stakeholder management
Key Requirements
Significant experience in sterility assurance and microbiological control
Proven experience in compliance management and health authority relations
In-depth knowledge of GMP requirements and regulatory frameworks
Expertise in sterile or low bioburden manufacturing
Ability to design and monitor effective contamination control strategies
Proven leadership ability to coach, develop, and grow a team