Director, Head of Clinical Quality Assurance

2 days ago

Bridgewater MA United States Gan & Lee Pharmaceuticals Full time

Summary

This position reports to the President and CEO of Gan & Lee Pharmaceuticals USA. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate.

Education and Credentials

  • College degree in a relevant field. Life Sciences Preferred.

Experience

  • At least 10 years in relevant quality auditor roles in which significant exposure to GCP/GLP has occurred.

Skills

  • Demonstrated ability to lead people in a positive manner.
  • Demonstrated ability to manage multiple and diverse projects concurrently.
  • Demonstrated ability to develop positive relationships and collaborations.
  • Strong analytical skills; a strategic thinker, planner, and implementer.
  • Reliable, dependable, and consistent worker.
  • Conscientious and extremely detailed oriented.
  • Strong ability to create practical and efficient processes.
  • Highly effective interpersonal skills, in individual as well as in group settings.
  • Strong communication skills (English), both written and verbal.
  • Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities:

Audits:

  • Prepare individual audit plans and audit/risk mitigation plans for larger projects/programs in support of Gan & Lee Annual Audit Plan.
  • Plan, conduct, report, and follow-up of internal audits, CRO and site audits, in accordance with current SOP(s).
  • Develop and maintain the GCP audit strategy in collaboration with senior QA leadership.
  • Perform vendor and clinical site evaluations, as required.
  • Clearly communicate and report (verbally and in writing) audit outcomes to the rest of organization, and escalate quality issues as required.
  • Support Gan & Lee Inspection Readiness Activities

Quality Systems:

  • Participate in developing, maintaining and improving of the Quality Management System and associated practices.
  • Participate in inspections performed by FDA and international regulatory agencies; also, audits performed by partners in own area of expertise.
  • Proactively identify analyses and leverage quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
  • Deliver input (e.g., GCP, Safety) on relevant projects to the manager and to Quality Management Review
  • Handle Deviations, Quality Issues, CAPAs, and changes as required in the clinical studies.
  • Provide support for SOP Review and Development

Training:

  • Provide input for GCP and other relevant training in QA and in the GCP area.

Knowledge/Regulation:

  • Represent QA in study team(s) where relevant and participate as appropriate to ensure clinical trials are conducted in compliance with clinical protocols, GCP and other regulatory requirements.
  • Review relevant project documentation for compliance with GCP and corporate standards.
  • Provide GCP expertise within the company as well as externally to vendors and service providers as needed.
  • Provide suggestions for continuous quality improvement in GCP.
  • Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant parts of the Gan & Lee Organization
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