Senior Clinical Quality Assurance Specialist

Additional Location(s):US-MN-Maple Grove; US-CA-Valencia; US-MA-Marlborough

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 high-performing 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.

*Please note this position can be based out of any US Based Office Location

About the role:
We are seeking an engaging and qualified Senior Clinical Quality Assurance Specialist who is aligned with Boston Scientifics core values: caring meaningful innovation high performance global collaboration diversity and winning spirit. A career with Boston Scientific is more than just a job its personal. We are committed to solving some of health cares toughest problems united by a deep caring for human life.

This hybrid role supports a global Clinical organization conducting investigational device trials at sites worldwide. If you are a natural problem solver with the imagination courage and drive to make a meaningful impact in clinical quality this is an opportunity to build your career while advancing patient care. Qualified U.S.-based candidates are encouraged to apply.

Work model sponsorship relocation:
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. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

Clinical compliance:

• Serve as the clinical quality representative on clinical trial project teams bringing the voice of clinical quality and fostering a continuous state of inspection readiness.

• Provide clinical quality consultation and respond to compliance and regulatory questions including quality review of clinical study documents and related functional study plans.

• Support the Inspection Readiness Program including inspection readiness training and coordination and participation in mock BIMO inspections and external inspections.

• Communicate with global clinical teams and Strategic Clinical Sourcing regarding clinical vendors including new vendor requests current needs and future requirements.

Independent auditing:

• Create risk-based study audit plans and plan schedule and conduct investigator site audits; support internal clinical process audits and clinical vendor audits as needed to ensure compliance with regulatory requirements quality standards GCP and Boston Scientific policies and procedures.

• Document and communicate audit observations evaluate impact and make recommendations for corrections and corrective actions.

• Evaluate responses to audit findings and ensure appropriate corrections and corrective actions are initiated and completed in a timely manner.

• Stay current on worldwide regulatory requirements and advise stakeholders on potential impacts of regulatory changes.

Clinical quality system:

• Support divisional and global Clinical and Quality System teams during external regulatory and notified body audits.

• Support the CAPA program by providing quality input for assessing internal noncompliance and recommending initiation of corrections and CAPAs partnering closely with Clinical CAPA teams and owners through successful closure.

• Participate in clinical and clinical quality continuous improvement initiatives and project teams.

• Review and provide input on relevant Boston Scientific procedure revisions.

• Support departmental divisional and corporate quality goals and priorities.

Acquisition integration:

• Represent Clinical Quality on acquisition and integration teams supporting the identification assessment and mitigation of risks associated with the review and/or transfer of sponsorship of acquired clinical studies to ensure compliance with applicable ISO 14155 GCP standards and regional regulations.

Qualifications:

Required qualifications:

• Bachelors degree with a minimum of 8 years experience in the medical device pharmaceutical or other GCP-regulated industry; or

• Associate degree in life sciences or nursing with active registered nurse licensure and a minimum of 8 years relevant experience.

• Demonstrated clinical research audit experience or transferable experience suitable for rapid development into a clinical study or investigator site auditing role such as clinical research associate or site monitor clinical trial coordinator GCP lead auditor clinical CAPA lead clinical research compliance professional or clinical research SOP author.

• Demonstrated experience in a clinical quality and/or health care research compliance role.

• Working knowledge of applicable regulations and standards including GCP Good Documentation Practices and privacy and security requirements for human subject research such as 21 CFR Partsand 11; EU MDR; ISO 14155:2020 and/or ICH E6; HIPAA; and GDPR.

• Independent reliable and professional team player aligned with Boston Scientifics mission vision and culture.

• Strong verbal and written communication skills with the ability to engage diverse stakeholders and appropriately escalate complex or challenging issues when needed.

• Ability to quickly learn and adopt quality system processes and adhere to organizational codes of conduct.

• Strong proficiency with electronic systems including understanding of user access controls and workflow validation processes.

• Ability to travel domestically and internationally up to 30%.

Preferred qualifications:

• RAQP-GCP SoCRA ACRP or equivalent certification.

• Experience maintaining compliance within a medical device manufacturer quality system or other clinical quality system.

• Experience interacting with regulatory authorities such as the U.S. FDA EU competent authorities Health Canada PMDA CFDA or BfArM.

• Minimum of 5 years direct clinical quality (GCP) auditing experience.

• Knowledge of EU MDR requirements.

• Demonstrated experience collaborating across complex cross-functional teams at all levels of the organization.

Requisition ID:623164

Minimum Salary:$85000

Maximum Salary: $161500

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 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.

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 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 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 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 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 Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specificprohibited substancetest 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.