Quality Consultant

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.

Created: 2025-02-21