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Associate Director, GCP QA and QA Systems

Company: Jasper Therapeutics Inc
Location: Redwood City
Posted on: May 31, 2024

Job Description:

Jasper is a biotechnology company focused on developing new therapies to treat both chronic and life-threatening diseases.Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision.$190,000 - $210,000 a yearPOSITION SUMMARYThis 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 QualityQUALIFICATIONS 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 validationOTHER KNOWLEDGE AND SKILLS - Strong working knowledge of ICH/FDA GXP (including GCP) regulations and guidelines - Proven ability to collaborate and communicate effectively - Proficient with MS Word, Excel, Sharepoint, Adobe Acrobat and DocuSign - Excellent organizational, time management, and project management skillsOUR VALUESRespect - Respect people; their diversity, time, values, feelings, needs and preferences - Be approachable, compassionate, kind and funCollaboration - Deliver via cross-functional project teams - Think to proactively share relevant information - Actively listen to seek to understand - Do not be afraid to ask for help - Keep a small company entrepreneurial mindset, be open and flexible about how you can contribute; lead like an ownerIntegrity - By always doing what is right by:o Colleagueso Patientso Doctorso The scientific processo Shareholderso EnvironmentResponsible - Follow up and deliver on commitments - Be accountable to our peers and teams, stakeholders, patients and doctorsExcellence - Be your personal best, set and live by high standards - Have a passion for excellence and embrace feedback - Embrace change, be innovative, creative and willing to challenge the status quoAcknowledgement - Real time reward and recognition, timely recognition of our peers with kudos - Share feedback proactively and constructively - Excellent performance must be encouraged, appreciated and rewardedSalary $190,000 - $210,000Jasper Therapeutics is an equal opportunity employe
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Keywords: Jasper Therapeutics Inc, Redwood City , Associate Director, GCP QA and QA Systems, Executive , Redwood City, California

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