Principal Clinical Quality Assurance Specialist

Your responsibilities will include: 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 clinical quality, compliance and regulation questions including quality review of clinical study documents and related functional study plans Supports Clinical Inspection Readiness program to include inspection readiness training and coordination, and participation in internal Mock BIMO inspections as well as external audits/inspections Evaluates responses to audit findings and ensures that appropriate corrections and corrective actions are timely initiated, documented and completed Supports Clinical and QS team during External Regulatory/Notified Body audits/inspections 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 in clinical process improvement projects and initiatives Provides reviews and comments in 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. Minimum of a bachelor's degree in Science, Health, Engineering, or a related field with minimum of 8 years' experience in the medical device, pharmaceutical, or other industry in an area regulated by GCP regulations and guidelines; OR in the alternative, a life science or Nursing Associate Degree with active Registered Nurse licensure and at least 10years of relevant clinical research experience Demonstrated clinical research audit, compliance and related writing experience with one or more of the following: clinical trial primary research coordinator or monitor, GCP auditor, CAPA leader, research compliance auditor, clinical research SOP author, or equally relevant role Demonstrated experience in Clinical Quality Assurance and/or healthcare research compliance 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), GCP (ISO14155 and/or ICH E6), HIPAA and GDPR Independent, reliable, professional, collaborative, team player aligned with BSC mission, vision, and culture goals Demonstrated experience and critical thinking with complex verbal and written communication to a variety of stakeholders, as well as successful conflict resolution skills and strong presentation skills - Must be proficient in English Strong electronic system adopter/user with understanding of system user access controls and workflow validations process Proficiency in MS Office apps WORD, Outlook, TEAMS, Excel, PowerPoint, SharePoint Ability to travel domestically and internationally up to 30% RAQP-GCP/ SoCRA, CCRP, CHRC, or ACRP certification or equivalent Experience with maintaining compliance with medical device manufacturer quality system or other clinical quality system requirements EU CA, Health Canada, PMDA, CFDA experience regarding clinical research, submissions and inspections 5 or more years of direct clinical quality (GCP) auditing experience Knowledge of EU MDR pertaining to clinical investigations of medical devices Non-English language(s) proficiency for reliable verbal and written audit related reviews and communication with EU investigational sites (e.g., France, Germany, Italy, Spain) Demonstrated experience communicating with all levels of a complex organization