Quality Sterility Assurance & Microbiology Lead

Responsibilities

• Develop and implement comprehensive sterility assurance and microbiology programs aligned with organizational strategy.
• Establish effective strategies for environment, water, steam, gas, bio-cleaning, gowning, and aseptic processes.
• Ensure product and process compliance with regulatory requirements and company quality standards.
• Maintain systems to identify, track, and mitigate sterility assurance and microbiological risks.
• Oversee production activities, including aseptic practices and contamination control.
• Collaborate with the Q&V team to oversee validation, qualification, and monitoring of methods and equipment.
• Monitor key performance indicators (KPIs) and metrics to identify trends and implement action plans.
• Lead critical microbiological events and define corrective and preventive actions (CAPA).
• Provide technical expertise and training programs for SA competency development.
• Prepare for and participate in regulatory inspections and audits.

Requirements

• 5 years of experience in sterility assurance and microbiological control within a pharmaceutical or biotechnology environment.
• In-depth knowledge of regulatory requirements and GMP (Annex 1, FDA guidance, Pharmacopeia).
• Expertise in aseptic processes, aseptic process simulation (APS), and environmental monitoring.
• Strong analytical and problem-solving skills within a GMP environment.
• Ability to establish effective working relationships with key stakeholders.
• Fluency in English and the local language.

About the Company

Sanofi is a leading global innovative pharmaceutical and healthcare company. Our Manufacturing & Supply Division is dedicated to using superior strategies and tools to manufacture high-quality medicines and vaccines, ensuring breakthroughs reach the patients who need them most.