OmniaBio: Sterility Assurance Manager

OmniaBio: Sterility Assurance Manager (12-month contract)

Hamilton, ON, Canada

Job Description

Posted Wednesday, January 7, 2026 at 5:00 AM | Expires Friday, January 16, 2026 at 4:59 AM

About OmniaBio:

OmniaBio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing with AI and automation. Located at McMaster Innovation Park in Hamilton, Ontario, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput. This innovative approach supports end-to-end CDMO services—from development through GMP manufacturing and scale-up—helping clients accelerate the path to market for transformative treatments. OmniaBio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting‑edge therapies worldwide. Visit www.omniabio.com to learn more.

Active Vacancy

Position Summary:
As the Manager, Sterility Assurance at OmniaBio, 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.

Responsibilities:

- Maintains a high level of expertise in sterility assurance to support manufacturing operations for OmniaBio and its clients.

- Creates and develops an aseptic strategy policy for OmniaBio 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 OmniaBio Operating Model continuous improvement philosophy.

Requirements:

- 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.

Desired Characteristics:

- 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.

OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.

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