Head of Quality Assurance

il y a 3 semaines

Paris, Île-de-France Meet Temps plein

Meet is in search of an experienced and proactive Head of Quality Assurance (QA) to spearhead and oversee our QA initiatives. As an integral part of our dynamic and agile team, you will play a vital role in ensuring that the highest quality benchmarks are achieved across all clinical and operational dimensions of our biotech projects. This position is essential for upholding compliance with regulatory standards, fostering continuous enhancement, and aiding in the advancement of innovative therapies.

Key Responsibilities:

  • Design, execute, and sustain a robust Quality Management System that adheres to regulatory guidelines (FDA, EMA, ICH, etc.).
  • Guarantee that all procedures conform to GxP standards (GMP, GCP, GLP).
  • Supervise the administration of Standard Operating Procedures (SOPs), ensuring they are up-to-date, effective, and properly executed.
  • Ensure adherence to all relevant regulatory requirements for clinical-stage biotech products.
  • Lead the preparation and management of regulatory inspections and audits.
  • Serve as the primary liaison with regulatory bodies regarding QA issues.
  • Provide QA oversight for all clinical trials, including the evaluation and endorsement of study protocols, clinical trial agreements, and informed consent documents.
  • Monitor and audit clinical trial sites, Contract Research Organizations (CROs), and other partners to ensure compliance with study protocols and regulatory standards.
  • Investigate and resolve any quality-related issues or deviations during clinical trials.
  • Collaborate closely with Research & Development, manufacturing, and clinical teams to ensure quality is embedded in the development process.
  • Offer QA support for Chemistry, Manufacturing, and Controls (CMC) activities, including batch record review and release, stability testing, and validation.
  • Lead and mentor a small QA team, cultivating a culture of quality and continuous improvement.
  • Manage day-to-day QA operations, including document control, internal audits, and quality issue investigations.
  • Develop and implement training programs to ensure all personnel are knowledgeable of and comply with quality standards.
  • Identify and execute opportunities for process enhancements to improve quality and efficiency.
  • Stay informed about industry best practices and regulatory updates, integrating them into the QA processes as necessary.

Experience:

  • Bachelor's degree in Life Sciences, Biotechnology, or a related discipline. An advanced degree is preferred.
  • A minimum of 8-10 years of experience in Quality Assurance within the biotech or pharmaceutical sector, particularly focusing on clinical-stage products.
  • Demonstrated expertise in GxP compliance, especially in GMP, GCP, and GLP environments.
  • A proven history of leading regulatory inspections and audits.
  • Hands-on experience with Quality Management System implementation and management in a small to mid-sized organization.

Why Consider this Opportunity?

  • Become part of a pioneering biotech organization committed to developing innovative therapies.
  • Engage in a collaborative and fast-paced environment with the potential to significantly influence the company's success.
  • Receive a competitive compensation package, including benefits and opportunities for professional development.

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