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 Bachelor's or Master's degree in a scientific field with over 7 years of experience in the pharmaceutical industry or equivalent. Strong grasp of Quality/Compliance standards as well as GCP and GLP guidelines. Diverse expertise in Clinical Quality Assurance practices. A self-motivated individual who excels both independently and as part of a collaborative team. Highly organized with exceptional attention to detail along with strong communication skills. Experience interacting with global regulatory authorities such as the FDA and EMA. Preferred: Experience in promoting a culture of GxP compliance within a startup environment. Location: [Insert Address]