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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