Director of Quality Assurance and Compliance

il y a 5 jours


Paris Louvre, Île-de-France Meet Temps plein

Job Summary:

Meet is seeking a highly experienced and skilled Director of Quality Assurance and Compliance to lead our Quality Assurance team and ensure the highest quality standards are met across all clinical and operational aspects of our biotech programs.

Key Responsibilities:

  • Develop, implement, and maintain an effective Quality Management System that aligns with regulatory standards (FDA, EMA, ICH, etc.)
  • Ensure compliance with all applicable regulatory requirements for clinical-stage biotech products
  • Act as the primary point of contact with regulatory agencies for Quality Assurance matters
  • Provide Quality Assurance oversight for all clinical trials, including the review and approval of study protocols, clinical trial agreements, and informed consent documents
  • Investigate and resolve any quality issues or deviations in clinical trials
  • Collaborate closely with Research and Development, manufacturing, and clinical teams to ensure quality is integrated into the development process
  • Provide Quality Assurance support for Chemistry, Manufacturing, and Controls (CMC) activities, including batch record review and release, stability testing, and validation
  • Lead and mentor a small Quality Assurance team, fostering a culture of quality and continuous improvement
  • Hands-on management of day-to-day Quality Assurance activities, including document control, internal audits, and quality issue investigations
  • Develop and implement training programs to ensure all staff are aware of and comply with quality standards
  • Identify and implement opportunities for process improvements to enhance quality and efficiency
  • Stay current with industry best practices and regulatory changes, incorporating them into the Quality Assurance processes as appropriate

Requirements:

  • Bachelor's degree in Life Sciences, Biotechnology, or a related field
  • Minimum of 8-10 years of experience in Quality Assurance within the biotech or pharmaceutical industry, with a focus on clinical-stage products


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