Job Description
Job Summary:
The Sterile Assurance Manager leads and manages sterility assurance activities at the manufacturing site, ensuring compliance with c GMP, 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 c GMP 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 c GMP standards.
The Sterile Assurance Manager leads and manages sterility assurance activities at the manufacturing site, ensuring compliance with c GMP, 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 c GMP 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 c GMP standards.
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