Sr Manager, QC Microbiology

Job Summary

The Senior Manager, QC Microbiology will lead, develop, and direct the QC Microbiology and Sterility Assurance programs at the site. This role will develop and maintain all documentation with regards to testing requirements and strategies and serve as a subject matter expert (SME) for microbiology and sterility assurance issues and provide technical expertise aligned with current GMPs and current industry practice.

Essential Functions

• Lead, manage and professionally develop all staff members.
• Oversee the execution of EMPQ, Cleaning Disinfection studies, and ensure a compliant site EM/Utility monitoring program.
• Manage, develop and maintain the Environmental Monitoring Program and prepare quarterly and annual trend reports and provide suggestions for continuous improvement.
• Accountable for, but not limited to, testing of raw materials (microbial testing), utilities/environmental monitoring and in-process/final product samples.
• Affirms that the QC laboratory operations are appropriately staffed and trained to meet both internal and external compliance (cGMP) requirements.
• Accountable for managing the sterility assurance program to ensure quality, product specifications and adherence to all current GMPs, ICH and FDA guidance documents, Annex 1, local procedures and Emergent Global standards.
• Ensure the laboratory remains current with all changes to applicable compendia and ability to implement changes in a timely manner.
• Review and approve technical protocols and reports.
• Review and approve out-of-specification (OOS) and out-of-trend (OOT) investigations and deviations.
• Manage relevant quality control activities and prioritize work to ensure site and project timelines are met.
• Interface with other departments and sites regarding special projects and quality issues.
• Cook up and supervise collection of testing, trending, and data reported in the Quality Management Review and Annual Product Review.
• Liaise with Regulatory Affairs and prepare/review documentation required for regulatory submissions and change controls.

Minimum Education, Experience, Skills

• Bachelor’s degree in Microbiology, Biology, Chemistry or related scientific field. Advanced degree (e.g. Masters) is preferred.
• 8+ years relevant experience within the vaccine and biopharmaceutical industry with experience in aseptic processing required.
• 5+ years of supervisory experience or demonstrated leadership role.
• Demonstrated knowledge in Sterility Assurance program is required.
• Demonstrated knowledge of GMPs and FDA requirements is required.
• Quality Systems experience desirable.
• Must be able to critically evaluate data summaries and conclusions.
• Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
• Must possess cGMP knowledge across all QC functions.
• Must have a knowledge and experience with cGMPs, 21CFR210, 211, 600, USP-NF, and Aseptic Processing Guidelines.
• Ability to influence without authority and influence within a highly matrixed organization.
• Excellent interpersonal skills both verbal and written.