Guerbet · 5 hours ago
Sterility Assurance Lead
Raleigh, NC
Full-time
Onsite
Senior Level
7+ years expGuerbet is a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions. The Sterility Assurance Lead is responsible for leading the site’s sterility assurance program, ensuring compliance with regulatory requirements, and maintaining a robust contamination control strategy.
Health CareMedicalPharmaceutical
Responsibilities
Develop, implement, and maintain the site-wide CCS in alignment with Annex 1 and FDA guidance. Lead cross-functional CCS reviews and updates, integrating new risks, CAPAs, and process changes. Provide technical guidance on contamination risks related to personnel, facility, utilities, equipment, and processes
Serve as the site expert on EU GMP Annex 1 requirements. Ensure sterility assurance practices align with current Annex 1 revisions, especially regarding risk-based aseptic practices, environmental monitoring, and CCS. Facilitate readiness and response to regulatory inspections focusing on Annex 1 compliance
Lead sterility risk assessments for aseptic processes, including media fill design and execution. Oversee the environmental and personnel monitoring programs; ensure trending, investigations, and timely responses to excursions. Evaluate and approve change controls, deviations, and CAPAs related to sterile manufacturing operations. Support batch release decisions with sterility assurance assessments, especially for sterility test investigations and atypical results
Ensure control of aseptic gowning, behavior, and personnel qualification programs. Oversee aseptic simulation (media fill) programs to verify operational performance and personnel aseptic technique. Evaluate and maintain effective use and integrity of barrier systems such as isolators, PACs, and HEPA systems
Analyzes and interpret project/study/investigation results and findings. Determines next steps under guidance of the manager and in compliance with applicable regulations; carries out technical and administrative duties as assigned. Responsible for review and approval QC test results as well as logbooks for accuracy and completeness and conformance to SOPs
Provide aseptic behavior and contamination control training to site personnel.Mentor and develop sterility assurance team members and provide subject matter expertise to cross-functional teams
Act as the SME during internal and external audits and inspections regarding aseptic and sterility assurance systems. Proactively identify and address potential compliance gaps
Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately
Other duties as assigned with or without accommodation
Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards)
Qualification
Required
Bachelor's Degree preferably in Microbiology, Biology or similar life science
7+ years of experience in sterile manufacturing (preferably in pharmaceutical manufacturing), with at least 3 years in a sterility assurance or microbiology leadership role
Preferred
Good interpersonal and verbal/written communication skills; able to use computer for data analysis
Deep knowledge of aseptic processing, cleanroom standards, isolator/PAC technology, EM programs, and sterility test methods
Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements
Self-motivated, energetic, enthusiastic, and team oriented
Strong understanding of EU Annex 1, FDA guidance, and other global GMP standards
Proven experience in risk assessment, contamination control strategies, and regulatory compliance
Ability to train personnel on various procedures
MS Excel, PowerPoint, Access, and investigation writing
Effective communication with both team members and other plant support groups
Company
Guerbet
Guebert is a pharmaceutical company based in France and is mainly focused on research.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$0.96M2022-09-26Post Ipo Equity· $0.96M
1999-04-01IPO
Leadership Team
François Convenant
Senior Vice President of Interventional Radiology
Recent News
2025-12-02
Company data provided by crunchbase