Director Clinical Quality Risk Management

Biosense, a member of Johnson & Johnson's family of Companies, is recruiting for a Director Clinical Quality Risk Management.

At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.

Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day. Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.

Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity!

The Director, MedTech Clinical Quality Risk Management advances the Quality Risk Management (QRM) objective, overseeing a robust GxP Quality Management System to enable a diverse portfolio of drug, medical device, and/or consumer health products and services.  This individual serves as a subject matter expert, providing guidance on compliance-related activities across the franchise business units in Good Clinical Practices (GCP), Pharmacovigilance (PV), and/or Good Documentation Practices (GDP).The Franchise QRM Head is a trusted advisor to the franchise Quality Head and Research & Development (R&D) functions, overseeing the establishment and execution of a Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, enterprise standards, and company policies and procedures. For the purposes of the job description, “franchise” may be defined as any of the Med Tech business franchises, Johnson & Johnson External Innovation, and/or the Consumer sector.

Key Responsibilities:

• Function as a trusted advisor to Franchise Quality Head and R&D business partners, providing subject matter expertise on applicable GCP/GLP/PV matters.
• Deliver periodic updates on the state of the applicable QMS to R&D, BRQC, Franchise Quality, and QRM Management.
• Develop and manage proactive risk management strategies in coordination with Franchise Quality and R&D leaders.
• @contextualize Key Quality & Risk Indicators (KQIs/KRIs) to provide risk-based insights and quality consultancy to primary stakeholders.
• Ensure timely escalation of critical issues arising from external bioresearch inspections, study and/ or program level noncompliance.
• Provide clinical quality leadership for studies including Collaborative, AGILE, and or JJEI studies in alignment with business priorities.
• Monitor evolving regulatory trends that may have a potential impact on the R&D business.
• Resolve compliance and regulatory issues with business leaders within the franchise.
• Oversee the development, implementation, and oversight of the applicable aspects of the franchise R&D and HMD QMS.
• Collaborate with BRQC Quality Assurance to ensure coordinated, risk-based audit planning and execution.
• Consult with business partners and BRQC peers to provide guidance on Quality Issues and Corrective and Preventative Action Plans (CAPA). Develop CAPAs, as required.
• Partner with Regulatory Compliance to develop and align to inspection strategies, including preparation, execution, and resolution activities for Health Authority Inspections.
• Coordinate with Regulatory Compliance, Business Development, and the R&D QRM Acquisitions & Divestitures team to integrate newly acquired assets and companies into the base BRQC operating model.