Principal Clinical QA Specialist

Recruiter: Spencer Gregory Hale

Principal Clinical QA Specialist

About the role: 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 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:

• Bachelor’s degree in Science, Health or relevant field of expertise
• Minimum of 10 years of work experience in the medical device/pharmaceutical/similar regulated industry
• Auditing experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines or equivalent relevant experience
• Lead auditor certified in ISO 13485
• High degree of integrity, professionalism, and ability to establish credibility
• Ability to travel

Preferred qualifications:

• Working knowledge of US and International regulations and standards applicable to BSC
• Working knowledge of ISO 14155, GCP, Real World Data Vendors and Digital Health Technologies
• Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.
• Experience working cross functionally with multiple stakeholders

Requisition ID: 610055 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 identify, gender expression, veteran status, age, 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.