Principal Clinical QA Specialist

Principal Clinical QA Specialist

The Principal Clinical QA Specialist will perform detailed clinical process and vendor audits to assure clinical research activities conform to federal and international regulations and BSC procedures. This is a global role that will audit clinical trials across all clinical divisions at BSC. Additionally, this role will work closely with clinical sourcing, clinical partnership, supplier quality, and software quality. Your responsibilities will include :

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical divisions.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits along with various SMEs (e.g. software quality) to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute to appropriate stakeholders.
• Own and manage related clinical vendor non-conformances.
• Review, understand, and audit clinical related regulations and guidelines (e.g. ISO, FDA medical device regs, GCP, etc.).
• Collaborate with clinical sourcing, supplier quality, and clinical partnership to manage clinical vendors.
• Support the preparation, coordination, and participation of regulatory agency inspections of BSC offices for clinical.
• Participate and support Clinical Quality Assurance Community of Practice quality improvement projects.

Required qualifications :

Preferred qualifications :

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, a e, mental or physical disability, genetic information or any other protected class. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.