Senior Manager Clinical Quality Assurance

ManagerSenior Manager Clinical Quality AssuranceKey ResponsibilitiesEstablishing robust GCP systems and processes in collaboration with the clinical operations team.Assist with Clinical Quality Assurance (CQA) efforts, including Trial Master File (TMF) and site auditing activities.Collaborate with clinical teams to ensure adherence to Good Clinical Practice (GCP) standards and internal protocols for clinical trials.Play a leadership role in assessing and contributing to clinical program planning and execution, including protocol reviews, informed consent forms (ICFs), corrective and preventive actions (CAPAs), and clinical study reports (CSRs).Provide quality oversight for clinical trial partners, such as Clinical Research Organizations (CROs) and contractors, while supporting the identification and onboarding of new third-party vendors as needed.Oversee the qualification and ongoing evaluation of GxP suppliers, ensuring significant findings are communicated to Quality Management and relevant stakeholders.Review clinical agreements to define roles, responsibilities, and communication protocols for quality-related tasks.Conduct internal and external audits, manage the investigation of findings, and oversee correctivepreventive actions, including root cause analysis and effectiveness checks.Qualifications and SkillsBachelor's or Master's degree in a scientific field with 7+ years of experience in the pharmaceutical industry or prehensive knowledge of QualityCompliance standards and GCP, GLPBroad expertise in Clinical Quality Assurance practices.Proactive, self-driven individual who thrives both independently and within a collaborative team environment.Highly organized with exceptional attention to detail and strong communication abilities.Experience engaging with global regulatory authorities such as the FDA, EMA, and others.Preferred: Experience fostering a culture of GxP compliance in a startup environment.

Created: 2025-02-21