Manager, Sterility Assurance

Manager, Sterility Assurance (12-month contract) Role Summary

As the Manager, Sterility Assurance at Omnia Bio, you will be responsible for designing, implementing and managing a sterility assurance and contamination control program within a cell and gene therapy manufacturing facility. You will provide technical expertise to define and execute the project plan and the ongoing support of the program. The person in this role will liaise closely with the Environmental Monitoring (EM) team embedded within the Quality Control (QC) department.

You will be a key member of the quality management team.

CA$/yr - CA$/yr

• Maintains a high level of expertise in sterility assurance to support manufacturing operations for Omnia Bio and its clients.
• Creates and develops an aseptic strategy policy for Omnia Bio including, but not limited to, room design, air flow regimes, air flow monitoring, temperature and humidity monitoring, room loads (equipment and personnel), gowning, cleaning regimes and air sampling.
• Creates, develops and implements an Environmental Monitoring Performance Qualification program.
• Provides guidance as a subject matter expert in the areas of microbiology, aseptic processing and contamination control.
• Develops sterility assurance standard operating procedures focusing on implementing regulatory requirements and phase-appropriate Good Manufacturing Practices (GMP) requirements.
• Manages an EM program to support current and future operations.
• Manages documentation for the EM program and studies data trending for the facility at regular intervals. Plans corrective action if any out-of-trend data are observed.
• Facilitates training of end-users on sampling requirements, sample handling and other quality procedures (if applicable).
• Provides quality oversight in the management of equipment logbooks/records and the preventative maintenance schedule for applicable equipment through collaboration with the facility management team.
• Reviews and approves deviations and above alert/action limit for the manufacturing facilities and liaises with other departments for timely resolution of these events.
• Manages third-party testing by our approved partners and contributes to the qualification processes (as required) of third-party laboratories.
• Manages the aseptic gowning qualification program and maintenance of personnel qualifications.
• Delivers quality-related services including product release, as contracted, to various cell and viral product-centered clients as and when required.
• Manages Sterility Assurance (SA) aspects for quality systems and the validation master plan, equipment qualification, computer systems, cleaning, analytical test methods and processes.
• Represents SA as a subject matter expert during client and regulatory audits.
• Supports validation by collaborating, reviewing and approving master qualification protocols, executed protocols and summary reports.
• Reviews and approves deviations, Corrective Action Preventive Action (CAPA) change controls, and other quality-related documents as required.
• Ensures GMP is embedded in all SA/EM-related tasks.
• Provides guidance and indirect leadership to the EM team and third-party contract staff.
• Engages and supports the Omnia Bio Operating Model continuous improvement philosophy.

• Bachelor of science degree in microbiology or biology.
• 8-10 years of industry experience.
• Knowledge of different sterilization modalities and contamination control approaches.
• Practitioner of risk management and comfortable in the use of risk analysis tools.
• Experience in the delivery of biological products for commercial supply.
• Understanding of Health Canada/US Food and Drug Administration GMP regulations and quality assurance principles.

• Capable of managing multiple projects simultaneously.
• Possesses strong verbal and written communication skills and is able to craft and deliver excellent presentations.
• Experienced in driving results and influencing without authority in a highly cross-functional environment.
• Demonstrates collaborative and encouraging management style.

Mid-Senior level

Contract

Quality Assurance

Biotechnology Research and Pharmaceutical Manufacturing