Director Clinical Quality Assurance

4 days ago

Fremont, United States SciPro Full time

A key client of ours are looking for an experienced Director of Clinical Quality to join their team during an exciting growth phase If you are passionate about making a difference in patients lives, and want to explore a new opportunity, look no further....


Responsibilities:


  • Apply advanced, international expertise in Good Clinical Practice (GCP) to develop, implement, and enhance cost-efficient, risk-focused quality assurance and compliance initiatives.
  • Craft and execute a strategic roadmap for GCP/GLP Quality Assurance to harmonize with organizational goals. Establish and cultivate the GCP/GLP Quality Unit.
  • Lead the establishment of a scalable, cost-effective, and risk-aligned quality assurance and compliance framework for overseeing clinical trials, ensuring site compliance, and monitoring safety.
  • Provide quality oversight for international clinical trials, offering consultation to program/study teams and conducting risk assessments.
  • Contribute to site activation, initiation, and qualification activities as necessary.
  • Formulate and manage the GCP audit strategy and plan, collaborating with program/study teams and adhering to program timelines and objectives. Conduct evaluations of vendors and clinical sites as needed.
  • Collaborate with cross-functional teams to address audit findings and implement corrective and preventive actions. Maintain and update the Corrective and Preventive Action (CAPA) process to ensure timely resolution of audit reports and actions.
  • Serve as the primary liaison with regulatory agencies, leading GCP health authority audits and inspections. Implement an Inspection Readiness program and provide leadership for GCP inspection readiness training. Offer technical support during regulatory inspections of investigator sites and participate in regulatory agency inspections.
  • Represent Quality Assurance (QA) in Program Teams, sub-teams, and study teams as required, providing guidance to ensure compliance with clinical protocols, GCP, and regulatory requirements.
  • Strategize inspection readiness activities to support program/study teams.
  • Develop and manage a robust quality management system to support clinical operations, including the development and implementation of policies, procedures, and processes aligned with industry standards and regulations. Continuously improve quality systems for efficiency and compliance.
  • Lead investigations into significant quality issues related to GCP elements, product handling, administration, or safety. Facilitate root cause identification and develop appropriate corrective and preventive actions. Ensure reporting of potential or confirmed violations to regulatory authorities.
  • Oversee the development, implementation, and maintenance of quality systems, processes, and procedures related to GCP/GLP and clinical trial oversight.
  • Recruit, train, and mentor a high-performing team of quality assurance professionals.
  • Foster collaboration with clinical development, regulatory affairs, clinical operations, patient operations, medical affairs, and other departments to ensure alignment in quality compliance activities. Provide guidance and support on quality-related matters.
  • Stay abreast of GCP legislation and relevant guidelines, integrating updates into organizational processes supporting clinical development.


Requirements:

  • Advanced degree in life sciences, pharmacy, or related field.
  • Minimum of 10 years' experience in GCP/GLP compliance and monitoring in biotechnology or pharmaceuticals, preferably with a focus on autologous and allogeneic cell therapy treatments.
  • Strong knowledge of FDA, EMA, and ICH regulations, particularly regarding cell and tissue studies.
  • Proven experience in developing and implementing quality systems in a clinical setting.
  • Demonstrated success in managing audits and inspections.

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