• Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs • Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision • Act as CQA lead representative at clinical study team meetings and other study related meetings • Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP • Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence • Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned • Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization • Assist in the development and/or delivery of GCP training topics and quality standards as directed • Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals • Collaborate with clinical functions to support inspection readiness activities • Perform key activities during regulatory authority inspection and/or external audits as directed by Head of CQA