Summary

Education and Credentials

• Bachelor’s degree in a relevant field. Life Sciences degree preferred.

Experience

• At least 5 years (or 3 years with a relevant advanced degree) in relevant quality assurance and/or clinical operations roles in which significant GCP work has occurred.
• Prior experience conducting GCP audits (including of vendors).
• Prior experience with participation in regulatory authority inspections will be considered an advantage
• ability to travel up to 30% as necessary.

Skills

• Strong communication skills (English), both written and verbal.
• Demonstrated ability to lead/influence teams in a positive manner with integrity and professionalism.
• 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 detailed oriented.
• Strong ability to create practical and efficient processes.
• Highly effective interpersonal skills.

Responsibilities

Audits:

• Maintain the GCP audit strategy in collaboration with senior  leadership.
• Plan, conduct, report, and follow-up on vendor, CRO, and site audits in accordance with current SOP(s) in support of Gan & Lee clinical development programs.
• Perform in-person vendor and clinical site oversight evaluations as required.
• Clearly communicate and report (verbally and in writing) audit outcomes to senior leadership, and document / escalate quality events as required.
• Drive Gan & Lee inspection readiness activities and initiatives.
• Participate in inspections performed by regulatory agencies and audits performed by partners.

Quality Systems:

• Contribute to the development, maintenance, and enhancement of the Quality Management System and associated practices.
• Proactively identify, analyze, and leverage quality indicators & data to determine potential trends. Identify risks to address and complete risk-based QA assessments to support the implementation of associated risk mitigation strategies.
• Manage GCP Quality Events, Deviations, and CAPAs, and all associated escalations in accordance with the QMS processes.
• Actively contribute to and lead SOP review and development.
• Oversee GCP activities, including (but not limited to) protocol reviews, investigator training, data integrity assessments, and regulatory submissions as relevant.
• Contribute to periodic QMS Management Reviews.
• Actively contribute to operational projects and processes.

Training:

• Provide input for GCP-related and other relevant training.
• Drive creation and assignment of training effecting GCP inspection readiness.
• Provide suggestions for continuous quality improvement in GCP. 

Knowledge/Regulations:

• Provide GCP expertise within the company as well as externally to vendors and service providers as needed.
• Maintain up-to-date knowledge of US, EU, and GCP legislation, guidelines, and practices, and ensure that information is distributed and acknowledged by relevant parts of the Gan & Lee Organization.
• 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.
• Foster a culture of quality and continuous improvement within the organization through communication, training, and recognition of achievements.