Principal Clinical Quality Assurance Specialist

Overview

Principal Clinical Quality Assurance Specialist – Onsite Location(s):
Arden Hills, MN, US, 55112. This role focuses on oversight and support of clinical research quality, with a strong emphasis on Good Clinical Practice (GCP). The position operates as both an independent auditor and a consultative quality partner to clinical teams, assessing compliance at clinical investigator sites and internally within the organization to ensure regulatory expectations, internal procedures, and best practices are met.

This role exists within a small, specialized clinical quality group distinct from broader design or manufacturing quality teams.

This role can be hybrid from the following locations: Arden Hills, MN;
Maple Grove, MN;
Marlborough, MA; and Valencia, CA.

This is a high-visibility hybrid position supporting a global Clinical team conducting investigational electrophysiology and cardiac rhythm management/diagnostic medical device studies at global sites.

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 foster and inspire clinical teams toward 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
• Owns and/or supports management of internal clinical, external investigator site and clinical supplier nonconforming event management and CAPAs
• Supports Clinical Inspection Readiness program including inspection readiness training and coordination, and participation in internal Mock BIMO inspections as well as external audits/inspections
• Communicates with internal stakeholders regarding clinical vendors, new clinical vendor requests, current clinical vendor needs, and future needs
• Creates risk-based study audit plans; plans, schedules, conducts, provides internal oral debriefs and writes formal audit reports to internal stakeholders and leadership for internal clinical quality audits, clinical process audits, investigator site audits, and clinical vendor audits to assure BSC clinical investigational pre-market, post-market and post approval clinical studies comply with applicable regulatory requirements, quality and GCP standards, and BSC policies and procedures
• Documents evidence and provides rational and authoritative citations for audit observations of nonconformance; communicates audit observations; evaluates impact and makes recommendations for corrections and/or corrective actions; evaluates responses to audit findings and ensures timely initiation, documentation and completion of corrections and corrective actions
• Keeps abreast of and interprets current worldwide regulatory requirements and good clinical practice standards; advises stakeholders regarding possible ramifications of regulatory changes

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

• Demonstrate an unwavering commitment to patient safety and clinical quality by adhering to the Quality Policy and all documented processes and procedures, maintaining a patient-centric quality focus
• 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 with Clinical CAPA team and CAPA owners through to 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

Acquisition integration:

• Represents 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…