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.