Sterility Assurance Director Firenze

Sterility Assurance Director
Firenze
Toscana, Firenze

For an international pharmaceutical company, we are looking for aSterility Assurance Director. TheSterility Assurance Directorwill be responsible for theSterility AssuranceStrategy, ensuring compliance with quality standards, GMP regulations, and industry best practices.

In this role you will manage a direct team, coordinate a multidisciplinary team and collaborate with other functions to ensure the microbiological integrity of sterile products. Key ResponsibilitiesDefine and implement thecontamination control strategy, ensuring compliance with international guidelines (EU GMP Annex 1, FDA, ISO). Oversee and improveEnvironmental Monitoring (EM)programs, Aseptic Process Simulation (APS), sterilization validation, and cleanroom qualification. Ensure proper application ofaseptic processing, sterilization, and microbiological risk management procedures. Lead preparation and management of regulatory inspections and internal/external audits. Provide technical support to production and quality departments in handling deviations, CAPA, and microbiological investigations. Promote continuous staff training on aseptic techniques, sterility, and contamination control. Assess and implement new technologies for improving sterility and aseptic processes. RequirementsDegree inMicrobiology, Biotechnology, Chemistry, Pharmacy, or related fields. At least 10 years of experienceinSterility Assuranceor Microbiological Quality Control, withat least 5 years in a leadership role. In-depth knowledge ofGMP, Annex 1, FDA Guidelines, and international regulations for sterile production. Experience in managingsterile environments, isolator technologies, terminal sterilization, lyophilization, and aseptic filtration. Strong team management skills and the ability to interact with regulatory bodies. Problem-solving skills, microbiological risk analysis, and strategic leadership. Excellent communication and interpersonal skills to work with cross-functional teams and stakeholders.