[Hiring] Senior Manager, Clinical Quality Assurance @Gan & Lee Pharmaceuticals

Role Description

This position reports to the Head of Clinical Quality Assurance at Gan & Lee Pharmaceuticals USA Corporation (Gan & Lee) or designee. The Senior Manager, Clinical Quality Assurance supports quality assurance activities related to clinical trials and research conducted during the development of pharmaceuticals, biologics, and medical devices. Additionally, the candidate will lead GCP activities and initiatives. This role will be based in either Denmark or the US.

Qualifications

• Bachelor’s degree in a relevant field; Life Sciences degree preferred.
• At least 5 years (or 3 years with a relevant advanced degree) in relevant quality assurance and/or clinical operations roles with significant GCP work.
• Prior experience conducting GCP audits (including of vendors).
• Prior experience with participation in regulatory authority inspections is an advantage.
• Ability to travel up to 30% as necessary.

Requirements

• Strong communication skills (English), both written and verbal.
• Demonstrated ability to lead/influence teams positively with integrity and professionalism.
• Ability to manage multiple and diverse projects concurrently.
• Ability to develop positive relationships and collaborations.
• Strong analytical skills; strategic thinker, planner, and implementer.
• Reliable, dependable, and consistent worker.
• Conscientious and detail-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).
  • Perform in-person vendor and clinical site oversight evaluations as required.
  • Clearly communicate and report 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 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 affecting 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.
  • 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 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.