Senior Clinical QA Specialist - GCP Auditor 598479

Additional Location(s): N/A

Diversity Innovation Caring Global Collaboration Winning Spirit High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and highperforming employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role: 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.

At Boston Scientific we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

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 nonconformances.
• 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:

• Bachelors 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 RQAPGCP etc.
• Experience working cross functionally with multiple stakeholders

Requisition ID:598479

Minimum Salary: $86600

Maximum Salary: $164500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see 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 nonexempt (hourly) nonsales 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 nonsales roles may also include variable compensation i.e. annual bonus target and longterm 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.

As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre a natural problemsolver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you!

At Boston Scientific we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion equality and opportunity for all. By embracing the richness of our unique backgrounds and perspectives we create a better more rewarding place for our employees to work and reflect the patients customers and communities we serve.

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.

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 COVID19 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 COVID19 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 Companys policies or protocols change with regard to COVID19 vaccination.