Senior Clinical Quality Assurance Specialist

Additional Location(s): US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

 

About the role:

The Sr Clinical Quality Assurance Specialist assists the Manager, Clinical QA, with internal quality assurance program for the assigned business area.  Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to ensure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures. Supports Inspection Readiness, Clinical Corrective and Preventative Action (CAPA) and acquisition integration.

 

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 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

 

 Quality system responsibilities:

• 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.

 

Required qualifications:

• Bachelor’s degree in Science, Health, or Engineering or a relevant field of expertise
• 5-7 years of work experience with quality systems/controlled processes
• Ability to travel up 30%

 

Preferred qualifications:

• Auditing experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines or equivalent relevant experience
• Working knowledge of US and International regulations and standards applicable to BSC
• Working knowledge of ISO 14155, GCP
• Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.
• Experience working cross-functionally with multiple stakeholders

 

 

 

Requisition ID: 606578 

Minimum Salary: $ 86600