Boston Scientific Senior Clinical Quality Assurance Specialist 

United States, Minnesota, Arden Hills 

898825847

Spencer Gregory Hale

Your responsibilities include:

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

• Provide clinical quality representation on clinical trial project teams to always foster and inspire clinical teams towards a state of inspection readiness
• Provide support and response to compliance and regulation questions including quality review of clinical study documents and related functional study plans
• Support Inspection Readiness program to include inspection readiness training and coordination/participation in Mock BIMO inspections as well as external audits and inspections
• Communicate with global clinical teams regarding clinical vendor compliance topics
• Keep abreast of and interpret current Clinical QS, worldwide Regulatory, and GCP requirements to situationally advise various stakeholders accordingly so to ensure human subject protection, data integrity and regulatory compliance in our clinical study conduct

Independent Auditing:

• Create risk-based study-specific audit plans; plan, schedule, and conduct investigator site audits per the study audit plan to ensure study conduct at the audited site complies with applicable Regulations and Good Clinical Practice standards
• Document and communicate audit observations to internal BSC stakeholders; evaluate impact and make recommendations for corrections and/or corrective actions.
• Evaluate responses to audit findings and ensure that appropriate corrections and corrective actions are timely initiated and completed, and audits are appropriately closed

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

• Support Clinical and QS team during External Inspections and Notified Body audits
• Support 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
• Participate on Clinical process improvement projects and initiatives
• Provide review and comment to relevant BSC procedure revisions
• Support departmental, divisional, and corporate quality goals and priorities
• Initiate and/or collaborate on continuous improvement projects related to the BSC Clinical Quality Management System.
• Participate in applicable Community of Practice

Acquisition integration:

• Represent Clinical Quality 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 3 or more years’ experience in the medical device, pharmaceutical, or other industry regulated by good clinical practice. We would also be open to applicants with a life science or nursing associate degree and an active registered nurse licensure (or equivalent) with at least 3 years of relevant clinical experience involving research.
• Demonstrated clinical research auditing experience with one or more of the following proficiencies: clinical research primary coordinator, site monitor, IRB or facility clinical quality representative, GCP educator, clinical research CAPA leader, clinical research compliance team member, or other applicable clinical research role
• Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance
• Familiarity with Regulations and GCP standards for conducting IDE Trials, including 21 CFR (50, 54, 56, 812, Part 11), GCP (ISO14155:2020 and/or ICH E6 R2), HIPAA and/or GDPR, paper and electronic Good Documentation Practices
• 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.
• Effective communication skills to understand divergent cross-functional stakeholder priorities and opinions while supporting/ensuring Quality goals.
• Strong electronic system adopter/user with understanding of system user access controls and workflow validations process
• Ability to travel domestically and internationally up to 30%

Preferred Qualifications:

• RAQP-GCP, SoCRA, CHRC or ACRP certification or equivalent
• Experience with maintaining compliance to medical device manufacturer quality system or other clinical quality system requirements
• FDA, EU CA, Health Canada, PMDA, CFDA, BfArM experience
• 5 or more years of direct clinical quality (GCP) auditing experience
• Non-English language(s) proficiency for reliable verbal and written audit related reviews and communication with EU investigational sites (ideally German, Italian, Spanish, Czech)
• Demonstrated experience communicating with all levels of the organization

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 aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.