Sr. Manager Sterile Assurance Group

Job Summary:

The Sterile Assurance Manager leads and manages sterility assurance activities at the manufacturing site, ensuring compliance with cGMP, FDA, and other regulatory standards. This role serves as the subject-matter expert (SME) for contamination control, environmental monitoring, aseptic processing, and sterilization protocols.

Key Responsibilities

• Develop and maintain contamination-control strategies across aseptic processing areas.
• Lead and enhance environmental monitoring (EM) programs, including trends analysis and risk mitigation.
• Conduct and oversee media fill simulations to validate aseptic processes.
• Guide sterilization processes and control programs, including validation and oversight.
• Manage deviations, change controls, CAPAs, and investigations related to sterility issues.
• Serve as SME during internal/external audits and regulatory inspections.
• Par...