Amazing Charts Technical Support Representative-1

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.