Sterility Assurance Manager

Summary:Lead and continuously improve the Sterility Assurance program for a pharmaceutical manufacturing site, ensuring all aseptic processes, environmental monitoring, and contamination control strategies meet regulatory and quality standards to protect product quality and patient safety.

Responsibilities

Oversee and coordinate Aseptic Process Simulations and smoke studies, ensuring compliance with regulatory and GMP requirements.Review and approve protocols, reports, SOPs, and risk assessments related to aseptic processing and sterility assurance activities.Manage changes impacting sterility assurance, including process modifications, equipment upgrades, and updates to contamination control policies.Drive continuous improvement initiatives for sterility assurance in collaboration with production and quality teams.Support and respond to sterility assurance inquiries from internal teams and regulatory authorities.Coach and mentor operators in aseptic practices to ensure proper behaviors and compliance.Lead investigations and timely closure of sterility deviations, out-of-specification results, and CAPAs.Contribute to quality KPIs, innovation, and operational efficiency while maintaining confidentiality and supporting additional tasks as needed.

Qualifications

Master's degree in Microbiology, Biotechnology, Biochemistry, Pharmacy, Chemistry, Chemical Engineering, or equivalent.8+ years of experience in the pharmaceutical industry, with a focus on Quality Assurance.Expertise in aseptic processing and Good Manufacturing Practice (GMP) implementation.Strong regulatory knowledge, including FDA Guidance on Sterile Drug Products Produced by Aseptic Processing and EudraLex Volume 4, Annex 1.Advanced knowledge of contamination control strategies.Proficiency in Microsoft Office suite applications.Ability to work independently, lead initiatives, and drive measurable improvements.Excellent problem-solving, communication, collaboration, and stakeholder management skills.Adaptability and resilience in a dynamic environment.Published Category: Quality & Validation