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

Job description

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. The Opportunity 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. Key Responsibilities: 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 performance. Support the investigation and resolution of supply chain quality issues. Ensure hosted processes meet regulatory and business requirements. Supplier and Service Provider Oversight Oversee the quality performance of relevant suppliers, distributors, service providers and contracted partners. Partner with host quality teams on supplier qualification, management and oversight. Regulatory and External Engagement Represent EP/NV Commercial Quality with health authorities and external stakeholders. Partner with Regulatory Affairs and industry associations on quality and post-market matters. Monitor emerging regulatory requirements and assess their business impact. Champion quality, compliance, customer safety and patient well-being. People Leadership Lead, coach and develop Commercial Quality team members. Build an engaged, inclusive and high-performing team culture. Drive talent development, succession planning and capability building. Manage departmental resources and budget effectively. About You Qualifications and Experience Bachelor’s degree in Biosciences, Engineering, Life Sciences, Pharmacy, Operations Management, Quality Management or a related discipline. At least 10 years’ experience in a regulated industry, such as medical devices, pharmaceuticals or healthcare. Demonstrated Quality and Compliance experience, preferably within the medical device sector. Proven people leadership, coaching and talent development experience. Strong expertise in Quality Management Systems, CAPA, risk management, post-market surveillance and audit management. Experience supporting health authority inspections, regulatory audits and compliance programmes. Strong cross-functional partnering and external stakeholder management capabilities. Experience working in matrix organisations and shared-service quality models is preferred. Technical Knowledge Strong knowledge of ISO 13485, MDSAP, Australian TGA regulations, New Zealand Medsafe requirements and applicable quality standards. Sound understanding of complaint management, adverse event reporting, field actions, recalls and post-market surveillance. Knowledge of supplier quality management and commercial quality operations. Strong understanding of quality risk management and continuous improvement principles. Core Competencies Credo-based leadership with strong strategic thinking and business acumen. Strong customer and patient focus, with a commitment to quality and compliance excellence. Sound risk management, decision-making and results orientation. Proven ability to lead change and drive continuous improvement. Effective collaboration, influencing, communication and stakeholder management skills. Strong matrix leadership, coaching and talent development capability. Why Choose Us: Competitive remuneration package Continuous training and support Award-winning leadership development programs Inclusive, flexible, and accessible working arrangements Equal opportunity employer supporting diversity and inclusion Our Benefits: Up to 18 weeks of parental leave to support new parents 4 days of volunteer leave to give back to the community Option to purchase up to 2 weeks of additional annual leave for extra time off Enjoy a dedicated Wellbeing Day to prioritise self-care Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities Access to an Employee Assistance Program for personal and professional support Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support Life insurance coverage for added peace of mind And much more... Great Place to Work® Certified – 2025 Great Place to Work® Certification recognises employers who create outstanding employee experience. The certification process is recognised worldwide as the global benchmark for identifying outstanding workplaces. Johnson & Johnson – Australia and New Zealand were certified as a Great Place to Work® in ANZ in its first year of partic