Lead Clinical Quality Assurance Manager

Lead Clinical Quality Assurance Manager

We are looking for an experienced and proactive individual to drive quality assurance in our clinical operations.

Key Responsibilities

• Develop and implement strong GCP systems and processes in partnership with the clinical operations team.
• Support Clinical Quality Assurance (CQA) initiatives, including Trial Master File (TMF) management and site audit activities.
• Work closely with clinical teams to ensure compliance with Good Clinical Practice (GCP) standards and internal clinical trial protocols.
• Lead efforts in clinical program planning and execution, including conducting protocol reviews, evaluating informed consent forms (ICFs), implementing corrective and preventive actions (CAPAs), and preparing clinical study reports (CSRs).
• Provide oversight for clinical trial partners such as Clinical Research Organizations (CROs) and contractors, and assist in the selection and onboarding of new third-party vendors.
• Manage the qualification and continuous assessment of GxP suppliers, ensuring that significant findings are reported to Quality Management and relevant stakeholders.
• Review clinical agreements to clarify roles, responsibilities, and communication protocols related to quality tasks.
• Conduct both internal and external audits, lead the investigation of findings, and supervise corrective / preventive actions, including root cause analysis and effectiveness checks.

Qualifications and Skills

Location : [Insert Address]