Adela is focused on the detection of cancer and other high-morbidity, high-mortality conditions through a blood test. The Company’s Whole-Genome Methylome Enrichment Platform has the unique ability to distinguish the most highly informative (methylated) regions of the genome from the non-informative regions and preferentially target those informative regions for sequencing. The technology is initially being developed for use across the cancer continuum for detection, diagnosis, and management and in the future will be applied to other conditions beyond cancer.
Reporting to the VP Quality and Regulatory, the Sr. Specialist, Clinical Quality will be responsible for leading, executing, and managing Quality and Regulatory activities related to Good Clinical Practices (GCP) and participate in the development and implementation of the GCP Quality Management Systems (QMS). This role will be responsible for leading and implementing Clinical Quality oversight of clinical studies to ensure compliance and effective processes are developed and maintained, per applicable regulatory requirements and company procedures.
· Create, implement, maintain, and continuously improve policies and procedures for GCP QMS per applicable regulatory requirements
· Provide support to cross functional teams for documentation review and approval to ensure GCP compliance and company procedures
· Responsible for overseeing the GCP audit programs, which includes supplier qualification audits and GCP internal audits. Includes developing performance metrics for applicable suppliers.
· Plan, execute, report, and follow-up on supplier and internal audits, which includes leading the audits, issuance of audit agenda/plan, audit report, and follow-up on audit findings until closure
· Develop, execute, and maintain a Quality governance and oversight program for clinical suppliers and monitor supplier quality performance metrics
· Manage the GCP QMS activities, such as CAPA, nonconformances, quality issues, study-related deviations, and audit programs until resolution
· Assist with root cause analysis, propose corrective and preventive actions, and oversee implementation of CAPA and perform effectiveness checks
· Measure quality, completeness, timeliness, and oversight of TMF and other document management systems in accordance with SOPs
· Identify, assess, and communicate GCP compliance risks to key stakeholders and oversee action plans to mitigate the risks. Includes monitoring compliance, quality, and efficiency of clinical operations processes in accordance with SOPs and GCP requirements.
· Lead organizational compliance to GCP and applicable regulatory requirements by providing continuous guidance, training, and education
· Partner with cross functional teams to drive inspection readiness activities and support regulatory authority inspections
· Ensure follow-up on all GCP external inspection findings including corrective and preventive actions and post-inspection activities for timely closure
· Manage IRB submissions for study level and site approvals
· 5+ years of experience of relevant Clinical Quality, Quality Compliance, Regulatory Compliance, and/or Clinical Compliance experience
· BS/BA in Biological Science, Medical Technology, or related field.
· Solid working understanding of ICH, GCP, US FDA, European and other regional clinical research regulations and guidance
· Experience in managing and overseeing clinical research vendors (CROs, Central Laboratories, Imaging, etc.)
· Familiarity with Good Clinical Laboratory Practices (GCLPs) preferred.
· Experience supporting inspection readiness activities and coordinating regulatory agency inspections
· Proven track record of building and implementing GCP QMS processes for regulated organizations
· Strong written and verbal communication and presentation skills.
· Demonstrated TMF management experience
· Successful history of IRB submissions and approvals
· Ability to work collaboratively across all functions within the organization and externally