The Clinical Quality Assurance Principal position is a leadership role supporting internal clinical quality assurance program and quality systems for the assigned divisional business area. This includes clinical compliance, internal and external quality audits, Inspection Readiness program, and, supporting clinical Corrective and Preventative Action (CAPA) and acquisition integration.
This person will work closely with the Regions Consultant Manager supporting a variety of diverse and exciting work content with an ability to gain global change management experience as well as influencing and driving change in our global functions.
Please note that this role can sit at any BSC location or remote site
Your responsibilities include:
Clinical Compliance: Hands on partnership with PMs for inspection readiness
Participates on clinical project teams and influence and encourage clinical teams towards a state of inspection readiness at all times.
Consultant support for compliance and regulation questions including quality review of clinical study documents
Facilitate Inspection Readiness program to include inspection readiness training and facilitate/coordinate Mock BIMO inspections.
Manage/coordinate BIMO sponsor inspection, and other regulatory agency sponsor inspections of BSC offices.
Preparation of investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs.
Clinical Quality System: Support to the Clinical organization in meeting BSC Quality system requirements
Support Clinical and QS team during External Regulatory/Notified Body audits
CAPA program; assessing internal noncompliance recommending initiation of NCEPs, Clinical CAPA team member working cooperatively with NCEP/CAPA owners providing quality input.
Acquisition integration: Act as the Clinical Quality lead on clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements.
Supports clinical teams in gathering and reporting various performance metrics by preparing slides and overall health statement for quarterly Business Unit Management Review meetings. Assess and provide relevant information for inclusion in the quarterly Executive Committee Management Review.
Participates on clinical process improvement projects and initiatives.
Supports departmental, divisional, and corporate quality goals and priorities.
Plans, schedules, and conducts external quality audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.
Plans, schedules, and conducts internal quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
Plans schedules and conducts clinical vendor assessments, qualification and periodic.
Review, revise, update and maintain Clinical AVL
Documents audit observations; evaluates impact, and makes recommendations for corrective actions. Evaluates responses to audit findings and ensures that appropriate corrective actions are completed.
Communicates observations to clinical investigators, clinical program managers, directors, and management
Contributes to the development of audit procedures and processes.
Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
What we’re looking for in you:
Bachelor’s degree and 8+ years relevant experience preferably in medical device industry
5 years clinical QA experience; minimum 3 years direct clinical quality (GCP) auditing experience
Ability to communicate with all levels of the organization
Travel of approximately 30- 50% can be expected
Telecommuting is allowed.
Internal Number: 416759
About Boston Scientific
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work