Manager, Electrophysiology & Neurovascular (EP/NV) Commercial Quality, ANZ

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: People Leader All Job Posting Locations: North Ryde, New South Wales, Australia Job Description: About MedTech Fuelled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalised treatments. Visit us at   https://www.jnj.com/medtech   to see how your unique talents will help patients on their journey to wellness.

You will lead the Commercial Quality function for Electrophysiology and Neurovascular products and services across Australia and New Zealand, managing a team of individual contributors and/or supervisors and ensuring effective performance management. You will direct quality operations to meet regulatory, customer, and business requirements; drives continuous improvement, risk management, compliance excellence, and quality system effectiveness; and partners with business leaders, cross-functional teams, host Commercial Quality organisations, supply chain partners, and external authorities to deliver compliant, high-quality products and services that improve customer and patient outcomes.

Commercial Quality Leadership Lead Commercial Quality activities for the EP/NV businesses across Australia and New Zealand. Execute quality strategies aligned with business priorities, regulatory requirements and customer expectations. Represent the customer, patient and Quality & Compliance perspective in business decisions. Serve as the primary Commercial Quality partner to ANZ EP/NV leadership. Quality Management System Execution Ensure effective execution and compliance of applicable Quality Management System processes. Partner with Surgery Commercial Quality to implement and maintain hosted QMS processes. Drive CAPA effectiveness, risk management and continuous improvement. Support audits, management reviews, regulatory inspections and remediation activities. Ensure quality issues are appropriately escalated, investigated and resolved. Post-Market Surveillance & Compliance Oversee complaint handling, adverse event reporting, vigilance activities, field actions, recalls and health authority reporting. Assess, manage and mitigate quality and compliance risks. Monitor quality performance and drive corrective and preventive actions. Support global quality initiatives and system improvements. Business Partnership & Operational Support Provide quality and compliance expertise across commercial and operational functions. Support compliant commercial activities, strategic initiatives and business planning. Provide quality support for new product introductions, lifecycle activities and business expansion. Proactively identify and mitigate risks through operational governance. Act as a trusted quality and compliance adviser to business leaders. Hosted Distribution & Supply Chain Quality Partnership Partner with Surgery Commercial Quality to ensure hosted distribution and warehouse processes address EP/NV needs. Provide quality oversight for logistics, loan kit operations, distribution changes and service-provider