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.
• Participate in cross-site sterile working groups and harmonize practices.
• Provide leadership, mentoring, and oversight to QA/QS staff and supervisors.
• Prepare and deliver performance reports—weekly, monthly metrics, and trend analyses.
• Collaborate with Operations on complaints, variances, and product issue escalation.

Qualifications & Experience

• Bachelor’s degree in Microbiology, Applied Biology, Life Sciences, or related discipline.
• Minimum 5 years of experience in sterile pharmaceutical manufacturing or a cGMP quality function
• Supervisory/management experience in a quality or technical team (5+ years preferred).
• Proficient in aseptic processing techniques, environmental monitoring, and sterilization validation
• Relevant hands-on experience with media fills and aseptic process simulations.
• In-depth knowledge of regulatory requirements including FDA, and cGMP standards.