Associate Director, Clinical Quality Assurance
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Clinical QA leader overseeing GCP compliance, audits, and inspection readiness for Artiva’s NK cell therapies. Partnering across clinical development to protect subject safety and data integrity.
Responsibilities:
- Serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development.
- Develop, implement, and conduct risk-based GCP quality oversight strategies.
- Lead investigations of significant GCP quality and compliance events, including CAPA development and effectiveness oversight.
- Plan, conduct, and manage contract auditors for routine and for-cause audits of clinical investigator sites, CROs, and vendors.
- Assess and communicate audit findings' impact on sponsor oversight, subject safety, data integrity, protocol compliance, and internal processes.
- Maintain required documentation and quality records.
- Lead inspection readiness activities and support regulatory authority inspections.
- Collaborate with internal teams to ensure quality compliance across clinical development.
- Define and implement review strategies for key regulatory documents associated with submissions.
- Lead development and implementation of clinical quality procedures with Clinical Development.
- Identify GCP compliance risks and develop mitigation actions.
- Monitor emerging regulations and communicate relevant changes.
- Provide QA consultation and participate in risk-based sponsor oversight activities.
- Define, support, and deliver GCP training for Clinical Operations staff.
- Define and present quality metrics and trend analyses.
- Participate in interviewing and hiring Clinical Quality Assurance staff.
Requirements:
- BS or BA in a scientific field.
- 8+ years of clinical and/or QA experience in biologics or pharma.
- 4+ years of Clinical QA experience.
- Knowledge and hands-on experience with regulatory inspections and clinical investigator site, vendor, and internal audits.
- Thorough knowledge of current Good Clinical Practices and Good Clinical Laboratory Practices for all phases of cell therapy product human clinical trials.
- Expert-level understanding of CLIA and CAP.
- Knowledge of ICH, GCP, GCLP, data privacy, and other applicable pharmaceutical/biopharma regulations and requirements.
- Sound scientific training and communications knowledge.
- Expert knowledge of quality regulations, current industry practices, and their interpretation and application.
- Computer skills required to operate Microsoft Word, Project, and Excel.
- Preferred: experience in small or emerging biotechnology companies.
- Familiarity with global pharmacovigilance regulations and quality systems preferred.
- Experience supporting or overseeing GVP quality activities, safety vendors, or pharmacovigilance processes preferred.
- Demonstrated understanding of the interface between GCP and GVP requirements preferred.
Benefits:
- A beautiful facility
- An entrepreneurial, highly collaborative, and innovative environment
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Recognition program, Bonus.ly, where you can trade in points earned for things you want
Similar Jobs
Linguistic QA Tester – Bulgarian
Linguistic QA Tester proofreading Bulgarian-localized content for Welocalize’s translation and AI content solutions. Identifying linguistic and functional defects across software, mobile apps, and documentation.
Senior General QA Engineer
Senior QA Engineer manually testing Gamingtec’s web, PWA, and mobile gaming applications. Executing functional, regression, API, and cross-browser tests while documenting and tracking defects.
Test Development Assistant
Test Development Assistant supporting NAEP and external assessment initiatives at nonprofit AIR. Reviewing assessment content, analyzing feedback, and coordinating partnerships and client engagements.
Data Tester
Data Tester validating financial data across legacy and target systems for Civica’s public-service software. Supporting migration testing, defect resolution, reconciliation, and go-live readiness.
QA Engineer
QA Engineer building AI-driven automated and exploratory tests for CARTO’s cloud-native location intelligence platform. Validating spatial analytics, data flows, maps, and test coverage.
Software Development Engineer IV – QA
Senior QA engineer designing automated UI, API, and event-driven testing for Jumio’s AI-powered identity verification platform. Improving release reliability across AWS microservices while mentoring QA engineers and championing responsible AI tooling.
Salesforce Manager, Quality Assurance & Consulting
Quality Engineering Manager leading Salesforce and AWS QA delivery for NeuraFlash, an AI and cloud innovation consultancy. Building automation, Agile practices, and a high-performing QA practice.
Automation Tester
Automation Tester at Capgemini executing automated test cases under QA lead supervision. Collaborating with QA teams and maintaining automation scripts for web, APIs, and mobile applications.
Software QA Engineer
Software QA Engineer focused on safeguarding workplaces and managing risks through collaboration and innovative solutions. Join a dedicated team making a significant impact in HR technology sector.
Senior Software Quality Engineer
Senior Software Quality Engineer at vCluster Labs managing test frameworks and strategies for a remote-first tech startup. Involvement in architecture discussions and CI/CD integration workflows.
Endpoint Management QA Engineer
Endpoint Management QA Engineer role focused on Microsoft Intune and Jamf Pro at Kubikware with a fully remote structure. Involves validating deployments and improving automation in testing workflows.
QA Engineer
QA Engineer responsible for enhancing platform quality and writing automated tests at Workwize. Collaborate with development teams for a streamlined user experience in remote IT equipment management.
Clinical Quality Assurance Coordinator
Clinical Quality Assurance Coordinator at MES ensuring quality and regulatory compliance in peer review reports. Working fully remote, managing reports aligns with client standards and mandates.
Clerical Quality Assurance Coordinator
Remote Clerical Quality Assurance Coordinator responsible for managing client report quality and compliance. Requires experience in clerical duties with medical office background preferred.
Quality Assurance Technician I
Quality Assurance Technician I reviewing customer product complaints for a medical device company. Assisting in documentation compliance and data processing with minimal supervision.
Integration QA Engineer
Integration QA Engineer focusing on back-end and integration testing for a UK Fintech project, collaborating closely with stakeholders and developers on complex API flows.
Analista Testing QA
QA Analyst testing and integrating projects for a customer service platform in the insurance sector. Focusing on functional testing and agile methodologies within a remote work framework.
QA Analista de Pruebas de Rendimiento
QA Analyst testing performance of critical applications in international telecommunications project; fully remote role with involvement in performance testing activities.
Software Developer, Engineer, Tester – Integrations
SDET focusing on ensuring quality of system integrations with MultiSpeak and SOAP web services. Collaborating with product teams and managing test cases and reports for effective software delivery.