Job Description

We are seeking a highly motivated Quality Consultant to support our biotechnology operations by ensuring compliance with industry regulations and driving continuous improvement in quality management systems. This role will involve collaborating with cross-functional teams to assess, enhance, and maintain quality standards across various processes. The ideal candidate will bring expertise in regulatory compliance, risk management, and process optimization, with a strong focus on ISO standards and industry best practices.

Key Responsibilities:

• Evaluate and refine Quality Management Systems (QMS) to ensure compliance with ISO 9001, ISO 13485, ISO 17025, and ISO 14971 , as well as other relevant industry regulations.
• Provide strategic guidance on quality-related initiatives , including risk assessment, CAPA (Corrective and Preventive Actions), and process validation to enhance operational efficiency.
• Conduct internal audits, gap assessments, and regulatory compliance reviews to identify areas for improvement and recommend corrective actions.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) and quality documentation in alignment with GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), and ISO standards .
• Support cross-functional teams in preparing for and responding to regulatory inspections and external audits by organizations such as the FDA, EMA, and ISO certification bodies .
• Advise on supplier quality management , ensuring vendors and partners adhere to established quality standards.
• Facilitate training programs to enhance awareness of quality and regulatory compliance requirements across the organization.

Qualifications:

• Extensive experience in quality assurance, regulatory compliance, or risk management within the biotech, pharmaceutical, or life sciences industry.
• Strong working knowledge of ISO 9001, ISO 13485 (for medical devices), ISO 17025 (for laboratory testing), and ISO 14971 (risk management for medical devices) .
• Proven ability to interpret and apply regulatory guidelines , including FDA 21 CFR Part 820, ICH Q10, and EU MDR .
• Excellent analytical, problem-solving, and project management skills.
• Ability to work independently and provide actionable insights to executive leadership and operational teams .

This position offers the opportunity to shape and enhance quality frameworks in a dynamic and evolving biotech environment , ensuring compliance with global regulatory expectations and industry best practices .

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