Sterility Assurance Program Manager

Position Summary

The Sterility Assurance Program Manager develops, implements, oversees, and continuously improves the sterility assurance program in a GMP-regulated manufacturing environment to ensure product sterility.

• Own and manage sterility assurance policies, procedures, and documentation.
• Develop/maintain programs covering sterilization validations, bioburden testing, endotoxin testing, and contamination control.
• Lead cross-functional sterility risk assessments and mitigation plans.
• Oversee sterilization/aseptic process validation and environmental controls.
• Plan, execute, and approve aseptic process simulations (media fills).
• Complete aseptic process validations (protocols, execution, data review, reports).
• Qualify and train manufacturing personnel in aseptic technique, contamination control, and sterility requirements.
• Produce technical reports for internal review and regulatory submissions.
• Ensure compliance with applicable regulations/standards (FDA/EMA/USP/ISO; EU GMP Annex
  1).
• Lead deviation investigations, root cause analysis, and CAPA.
• Support regulatory inspections/audits as SME; monitor and report sterility metrics.

• Strong knowledge of aseptic processing, sterilization, contamination control, microbiological testing, media fills, and process validations.
• Experience qualifying/training manufacturing personnel.
• Experience owning/executing/reporting aseptic process validations.
• In-depth knowledge of EU GMP Annex 1; familiarity with FDA cGMP, EMA, USP, ISO 13485.
• Risk management experience (e.g., FMEA, HACCP).
• Analytical, problem-solving, project management, and documentation skills.

• Bachelor’s in Biology, Microbiology, or Engineering (advanced degree preferred).
• 5+ years in sterility assurance/quality assurance in GMP manufacturing.

• Sterile dosage form manufacturing; eQMS proficiency; advanced degree.