POSITION SUMMARY

This position will support the GCP QA function at Jasper Therapeutics, executing GCP QA activities related to clinical product development and clinical studies. The incumbent will interact cross-functionally to provide GCP and compliance support for ongoing and new clinical studies led by Jasper. This position will also lead development and management of quality systems, providing support for GxP computerized systems as applicable. The role will include performing QA reviews of documents as required. This position will report to the Vice President, Head of Quality.

RESPONSIBILITIES

· Provide GCP QA oversight and support cross-functionally and to GCP vendors.

· Provide GCP QA guidance in project and team meetings, and form collaborative relationships with other functional areas to ensure the delivery of high quality clinical data

· Serve as the QA lead for the development and management of GCP QA and clinical SOPs and other quality documents

· Manage and develop GXP quality systems processes and procedures

· Support implementation, validation, and maintenance of computerized systems related to quality systems and clinical activites, as applicable

· Conduct QA review of clinical documents as required

· Ensure the timely and effective follow up of all identified or assigned clinical quality issues, and escalate as appropriate

· Provide guidance for investigations and corrective and preventive action (CAPA) plans for compliance issues and/or observations

· Ensure quality assurance audits of clinical investigator sites and GCP vendors are conducted to assure compliance with clinical protocols, regulatory requirements and guidelines

· Manage Data Privacy compliance and escalate issues to senior management as necessary

· Support inspection readiness initiatives internally and with GCP vendors and clinical investigator sites

· Contribute to strategic organizational and budget planning for Quality

QUALIFICATIONS AND EXPERIENCE

· 10+ years’ experience in Quality Assurance in a biotech or pharmaceutical environment, with 2+ years’ experience in GCP QA

· BA or BS degree in a scientific discipline

· Experience working with Contract Research Organizations and Contract Laboratories

· Experience with eQMS systems and computerized systems validation