Boston Scientific Senior Clinical QA Specialist - GCP Auditor 

United States, Massachusetts, Marlborough 

771599701

The Senior 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 5 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
• 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
• High degree of integrity, professionalism, and ability to establish credibility
• Lead auditor certified in ISO 13485
• Additional quality certifications from ASQ, SOCRA, RQAP-GCP, etc.
• Experience working cross functionally with multiple stakeholders

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.