Senior Specialist Clinical Quality Assurance

Additional Locations: Netherlands-Kerkrade; Germany-Düsseldorf

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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.

We are seeking an engaging and qualified Senior Clinical Quality Assurance Specialist who is aligned with our core values that define Boston Scientific culture and empower our employees: Caring - Meaningful innovation - High performance - Global collaboration - Diversity - Winning spirit.  Because a career with Boston Scientific is more than just a job. It’s personal. We’re committed to solving some of healthcare’s toughest problems – united by a deep caring for human life. If you’re a natural problem-solver with the imagination, courage, and spirit to make a meaningful difference in clinical quality, there’s no better place to build your career.

This is a remote position supporting a global Clinical team conducting investigational device trials at global sites.  Qualified candidates are encouraged to apply.

Your responsibilities will include:

Clinical Compliance - Hands-on partnership with Clinical for clinical quality consultation and inspection readiness:

• Provides clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
• Provides support and response to compliance and regulation questions including quality review of clinical study documents and related functional study plans
• Supports Inspection Readiness program to include inspection readiness training and coordination/participation in Mock BIMO inspections as well as external inspections
• Communicates with global clinical teams and Strategic Sourcing regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs

Independent Auditing:

• Creates risk-based study audit plans; plans, schedules, and conducts investigator site audits, and may co-audit internal clinical process audits, to assure BSC clinical investigational trials and post market studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures
• Documents and communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions. Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated and completed
• Keeps abreast of and interprets current worldwide regulatory requirements; advises various stakeholders regarding possible ramifications of regulatory changes 

Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements

• Supports Clinical and QS team with inspection readiness and responding to internal and external audits
• Supports the CAPA program, providing quality input for assessing internal noncompliance and recommending initiation of corrections/CAPAs, working closely with Clinical CAPA team and CAPA owners through to successful closure
• Participates on clinical process improvement projects and initiatives
• Provides review and comment to relevant BSC procedure revisions
• Supports departmental, divisional, and corporate quality goals and priorities 
• Initiates and/or collaborates on continuous improvement projects related to the BSC Clinical Quality Management System.

Acquisition integration:

• Supports Clinical Quality input on clinical acquisition/integration teams for identification, assessment, and mitigation of risks associated with the transfer of sponsorship of clinical studies from acquired entities, supporting development and execution of a clinical integration plan, transfer of quality systems, and compliance to GCP and applicable regulations with aim to ensure subject safety and integrity of study data.

What we're looking for in you: 

Minimum Qualifications:

• Minimum of a bachelor’s degree with minimum of 3 years’ experience monitoring and/or auditing medical device and/or drug trial investigator sites OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 3 years of relevant clinical trial experience.
• Demonstrated clinical research audit experience OR suitability to quickly train into clinical study/investigator site auditing role, with one or more of the following proficiencies: clinical research associate/site monitor, clinical trial primary research coordinator, GCP lead audit, research compliance, clinical research SOP author
• Working knowledge of regulations, standards, paper and electronic Good Documentation Practices, and privacy/security obligations relevant to conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11) and/or other regional Medical Device investigational trial regulations, GCP (ISO14155:2020 and/or ICH E6 R2), HIPAA and/or GDPR
• Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals
• Demonstrated experience with complex verbal and written communication to a variety of stakeholders, as well as successful conflict resolution skills
• Strong electronic system adopter/user with understanding of system user access controls
• Ability to travel domestically and internationally up to 30%
• Office  Based in Belgium 2 days/week

  Preferred Qualifications:

• Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance
• Experience with IDE Trials
• Working applied knowledge of 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155:2020 and/or ICH E6 R2), HIPAA and GDPR
• RAQP-GCP/ SoCRA or ACRP certification or equivalent
• Experience with maintaining compliance to medical device manufacturer quality system or other clinical quality system requirements
• EU CA, Health Canada, PMDA, CFDA, BfArM experience
• Clinical quality (GCP) auditing experience
• Knowledge of EU MDR
• Non-English language(s) proficiency for reliable verbal and written audit related reviews and communication with EU investigational sites (Germany, Italy, Spain)
• Demonstrated experience communicating with all levels of the organization

Requisition ID: 560425

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!