About Afynia:

Afynia is a pioneering medical diagnostic startup company dedicated to advancing women's health through innovative diagnostic solutions. Our mission is to transform patient care by leveraging state-of-the-art technologies and novel approaches in molecular biology and bioinformatics. We are looking for a skilled and passionate Laboratory Operations Manager to join our dynamic clinical laboratory team to enhance our groundbreaking work.

Job Summary:

We are seeking a highly motivated and action-oriented Laboratory Operations Manager to drive the execution of critical projects across our laboratory and business operations. This role is ideal for someone who thrives in a fast-paced, regulated environment and can effectively lead cross-functional initiatives spanning regulatory compliance, product development, laboratory operations, and commercialization. Reporting directly to the CSO, the Laboratory Operations Manager will play a key role in translating strategic priorities into actionable plans and ensuring successful delivery from concept through completion. This individual will collaborate closely with regulatory, quality, R&D;, and operations teams to maintain alignment with company objectives while meeting industry and regulatory standards. This is a full-time, in office position based in Afynia's Hamilton laboratory. The ideal candidate brings strong project management capabilities, exceptional organizational skills, and the ability to proactively identify risks, solve problems, and drive results in a dynamic, high-growth environment.

Key Responsibilities:

- Lead planning and execution of projects related to product development and operational initiatives.
- Define project scope, timelines, deliverables,



and resource requirements in collaboration with cross-functional teams and stakeholders.
- Track progress against milestones, ensuring projects are delivered on time, within budget, and in compliance with regulatory standards.
- Collaborate with regulatory, quality, R&D;, operations, and leadership teams to support project success and operational logistics.
- Support implementation and maintenance of GLP, QMS, and risk-based compliance frameworks.
- Develop and maintain SOPs, logs, and documentation to support audits and regulatory submissions (e.g., ISO, COLA, CLIA, Health Canada, FDA).
- Monitor regulatory requirements and integrate compliance milestones into project plans.
- Track inspection readiness and regulatory progress, including COLA accreditation.
- Monitor project performance, track KPIs, and provide regular reporting to leadership on status, risks, and outcomes.
- Identify, assess, and mitigate project risks (technical, regulatory, operational) in collaboration with leadership.
- Develop contingency plans and lead risk review processes to minimize disruptions.
- Drive problem-solving using data-driven decision-making while balancing quality, compliance, and efficiency.
- Escalate critical issues and support timely resolution.

Qualifications:

- Bachelor's degree in a relevant field (e.g., business, science,



healthcare or related); life sciences or biomedical background considered an asset.
- 3-7+ years of experience in project management within a related environment (e.g., diagnostics, healthcare, biotech or laboratory setting).
- Demonstrated experience working with regulatory frameworks and standards (e.g., ISO 15189/13485, CLIA, COLA, GLP or QMS).
- Proven ability to manage cross-functional projects and deliver within defined timelines and budgets.
- Experience developing and maintaining SOPs, documentation and audit readiness processes.

Preferred Skills:

- Background or experience in life sciences, diagnostics, or laboratory environments.
- Strong knowledge of regulatory submission processes and accreditation requirements (e.g., Health Canada, FDA, Accreditation Canada).
- Excellent project management skills, including planning, prioritization, and resource coordination.
- Experience tracking KPIs, analyzing performance data, and reporting to senior leadership.
- Strong risk management and problem-solving capabilities with a proactive, solutions-oriented mindset.
- Exceptional communication and stakeholder management skills, with the ability to collaborate across technical and non-technical teams.
- High attention to detail with a focus on quality, compliance, and continuous improvement.
- Experience in a startup or fast-paced environment is an asset.
- Familiarity with project management tools and quality management systems.

What We Offer:

- Salary range of $85,000 - $110,000 based on skills and experience.
- Opportunity to work in a fast-paced startup setting with a dynamic and collaborative environment.
- Professional development and training opportunities.

📌 Laboratory Operations Manager (Canada)
🏢 Afynia Laboratories
📍 Canada