Quality Assurance Director

6 days ago

Toronto, Ontario, Canada AssureBio Full time

An industry-leading life sciences organization, AssureBio, seeks a highly experienced professional to lead its Quality Assurance and Regulatory Compliance functions. 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.

Requirements:

  • 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.

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