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 detail-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 the organization, and escalate quality issues as required.
- Support Gan & Lee Inspection Readiness Activities.
Quality Systems:
- Participate in developing, maintaining, and improving 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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