Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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.
Principal Clinical Quality Assurance Specialist
** This position can be field based anywhere in the U.S. (Remote)
About the role:
- Develops, establishes and maintains Clinical Quality Assurance programs, policies, processes, procedures and controls governing the Interventional Cardiology Clinical Function. Partners with Clinical trial teams to ensure the efficient and compliant implementation of the good clinical practices regulations/standards. Conducts clinical audits at investigator sites and clinical vendors.
- Your responsibilities will include:
- Leads the clinical quality assurance team in the development of clinical audit procedures and processes.
- Subject matter expert on GCP regulations/standards in order to support the Clinical organization in meeting BSC Quality system requirements
- Plans, schedules, and conducts desktop vendor audits
- Plans, schedules and conducts desktop process/document audits
- Conducts investigator site audits
- Drives improvements in the clinical organization through the CAPA process, working cooperatively with Clinical NCEP/CAPA owners and Quality Manager providing quality input
- Leads annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
- Partners closely with Corporate clinical quality assurance group on cross-divisional initiatives
- Leads the preparation, coordination, and management of regulatory agency sponsor inspections
- Mentor CQA specialists with less experience and influence the quality culture across the IC Clinical organization
What we are looking for in you:
- Bachelor’s degree in Life Sciences and 7-10 years of experience
- Experience in medical device or pharmaceutical industry in an area regulated by GCP regulations and guidelines
- Demonstration of BSC Core Values and growth mindset
- Up to 30% domestic and international travel required. Note: COVID-19 precautions currently restrict travel. At Boston Scientific, our priority is to protect and aid the health and safety of our employees, our physician customers, and their patients.
- Master’s degree in Life Sciences preferable
- Clinical QA and/or compliance experience preferred
- GCP auditing certification desired
Requisition ID: 483275
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) isn’t just business, it’s personal. And if you’re a natural problem-solver 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 is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.