Inspection Readiness Associate (Compliance)

Active Vacancy 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. Position Summary: As Inspection Readiness Associate, at OmniaBio, you will be responsible for all aspects of inspection readiness including client audits and regulatory inspections. You will ready the organization for audits and inspections through a variety of initiatives, using quality metrics, self-inspection (internal audit), and regulatory intelligence. The role will liaise closely with all team members operating in the Good Manufacturing Practices (GMP) environment, along with external stakeholders and regulators. You will be a key member of the Quality Compliance team. Responsibilities: Maintains a high level of expertise in GMP compliance with respect to cell and gene therapy manufacture and well as all aspects of GMP compliance. Plans for all client and regulatory audits including setting agenda and timing Organizes SMEs and functional representation for all audits Works closely with business unit leaders to ensure that OmniaBio are audit ready all all times Works closely with business unit leaders and SMEs to ensure that audit responses and commitments are complete within the allotted time(s). Hosts health authority and client audits where applicable Maintains current understanding of GMPs and evolving regulations, and owns OmniaBio’s compliance standards. Engages and supports the OmniaBio Operating Model continuous improvement philosophy. Requirements: Bachelor of science degree in science or engineering. 5-10 years of equivalent industry experience. Must have knowledge of compliance aspects of cell and gene production, sterile manufacture and overall GMP knowledge. Experience hosting client and regulatory audits Experience preparing responses to audits and managing audit commitments Excellent understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and QA principles. Desired Characteristics: Capable of managing multiple projects. Strong presentation skills and English written and oral communication skills. Experienced in driving results by influencing others in a highly cross-functional environment. Demonstrates a collaborative and enabling 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.

The role is responsible for managing all aspects of inspection readiness, including planning and hosting client and regulatory audits. It involves collaborating with SMEs and business leaders to ensure GMP compliance and timely completion of audit commitments.

Candidates must have a Bachelor's degree in science or engineering and 5-10 years of industry experience in GMP environments. Expertise in cell and gene production, sterile manufacture, and Health Canada/FDA regulations is required.

• Quality assurancePreferred
• Project managementPreferred
• Stakeholder ManagementPreferred

Identified from the job description. Confirm important requirements above.

• GMP Compliance
• Inspection Readiness
• Regulatory Audits
• Quality Assurance
• Cell and Gene Therapy
• Internal Auditing
• Regulatory Intelligence
• Project Management
• Stakeholder Management
• Sterile Manufacture
• Health Canada Regulations
• FDA Regulations
• Technical Writing
• Cross-functional Leadership
• Quality Metrics
• Audit Response Management

• Manufacturing
• Science & Research
• Healthcare
• Engineering
• Management & Leadership

Minimum education

Bachelor’s degree

Minimum experience

5+ years

Apply by

Sep 26, 2026

Posting language

English

Working hours

40 hours per week

Seniority

Associate

Application method

Direct apply is available