Sr. Clinical QA Specialist

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

Quality System Requirements:

• In all actions demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

• Assures that appropriate resources (personnel tools etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.

• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

• Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues.

What were looking for in you:

Required Qualifications:

• Bachelors degree in science health engineering or a relevant field of expertise

• 5-7 years of work experience with quality systems/controlled processes

• Previous experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines

• Strong presentation communication and critical thinking skills

• Strong understanding of Quality Systems

• Working knowledge of ISO 14155 and GCP

• Working knowledge of ISO 13485

• NCEP CAPA and Supplier Corrective Action experience

Preferred qualifications:

• Working knowledge of US and International regulations and standards applicable to BSC

• Additional quality certifications from ASQ SOCRA RQAP-GCP etc.

• Experience working cross-functionally with multiple stakeholders

• NCEP CAPA and Supplier Corrective Action experience

• Ability to collaborate and influence across multiple cross-functional teams