Sr. Clinical QA Specialist

Recruiter: Spencer Gregory Hale

 

 

Sr. Clinical QA Specialist 

 

About the role: 

Assists the Manager, Clinical QA, with internal quality assurance program for the Interventional Cardiology (IC) Business unit.  This role ensures clinical trial compliance and inspection readiness by assessing protocol, GCP, and regulatory adherence, evaluating data quality, and supporting issue resolution. It contributes to audit planning, NCEP/CAPA/SCAR processes, and regulatory inspection preparation. The role collaborates cross-functionally to address nonconformances, perform root cause analysis, and verify corrective actions. It supports IC Clinical Quality Assurance activities, communicates quality signals, and drives continuous improvement. Additionally, it helps develop and maintain global quality systems to enhance compliance and proactively advises on regulatory changes. 

 

Your responsibilities will include: 

• Participates in clinical project teams, and always influences clinical teams toward a state of inspection readiness  

• Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials 

• Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures  

• Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials  

• Participates in problem-solving with clinical project teams at investigator sites  

• Communicate observations to clinical investigators and clinical program managers 

• Documents audit observations; evaluates impact and responses to audit findings and ensures the appropriate corrective actions are completed  

• Ensures tracking of audit findings  

• Contributes to the development of audit procedures and processes 

• Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives 

• Assists in the preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings  

• Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes 

• Support the Clinical organization in meeting BSC Quality system requirements  

• Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners and providing quality input  

• Partner with Clinical to support supplier and BSC-related nonconformances by performing the following activities (NCEP, CAPA, SCARS): 

• Conduct root cause analysis 

• Determine corrective and preventive actions 

• Determine verification of effectiveness actions to support the corrective and preventive actions  

• Support IC CQA portfolio activities and quality system deliverables for IC CQA, including but not limited to quarterly audit schedule updates, management of IC CQA surveillance activities, communication of quality signals to quality leads and clinical leadership, and coordination of clinical and clinical quality QMR deliverables for ICTx and WM.  

• Proactively drive clinical compliance, making data-driven decisions to facilitate process improvement and a proactive quality culture. 

• Participates in the development, implementation, and maintenance of global quality systems. Works to identify ways to improve compliance with regulations and BSC policies and procedures for CQA