Head of Quality

4 weeks ago

Toronto, Ontario, Canada AssureBio Full time

An industry-leading life sciences organization is seeking a highly experienced Head of Quality to lead its Quality Assurance and Regulatory Compliance functions.

Exclusive to AssureBio , this critical leadership role is responsible for ensuring that all quality systems, processes, and regulatory frameworks align with international standards and industry best practices.

Key Responsibilities:

  • Quality Leadership & Continuous Improvement: Develop and implement strategic quality initiatives to enhance operational efficiency, regulatory compliance, and overall business performance.
  • Regulatory Compliance & Risk Management: Oversee adherence to international regulatory standards, including ISO 13485, 21 CFR Part 820, FDA regulations, EU MDR, and other relevant global requirements.
  • Audit & Inspection Management: Serve as the primary liaison for regulatory authorities, leading audits, inspections, and subsequent action plans to maintain compliance and drive excellence.
  • Stakeholder Collaboration: Work closely with cross-functional teams, industry partners, and regulatory bodies to address product quality, customer satisfaction, and compliance challenges.
  • Process Optimization & Operational Efficiency: Ensure that quality systems are robust, scalable, and aligned with business objectives, with a focus on process improvement, efficiency, and profitability.

What we are looking for:

  • Extensive Quality Management Experience: Proven leadership within the medical device, pharmaceutical, or life sciences sector, with a strong background in quality systems and regulatory compliance.
  • Regulatory Expertise: In-depth knowledge of GxP, ISO standards, FDA regulatory requirements, and international compliance frameworks.
  • Risk Management Proficiency: Experience applying FMEA, FTA, and ISO 14971 methodologies to proactively identify and mitigate quality risks.
  • Strategic Leadership & Influence: Strong stakeholder engagement, negotiation, and team leadership skills within a matrixed organization.
  • Technical & Analytical Acumen: Ability to assess and improve quality processes while ensuring compliance with evolving regulatory expectations.

Qualifications:

  • Bachelor's Degree in Life Sciences, Engineering, Quality Management, or a related field (Master's degree preferred).

This is an exceptional opportunity to lead a high-performing Quality function within a globally recognized organization. If you have the expertise and vision to drive regulatory excellence and continuous improvement, we invite you to apply.

For a confidential discussion or to express interest, please get in touch.

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