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 (https://www.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: Professional All Job Posting Locations: North Ryde, New South Wales, Australia Job Description: Great Place to Work® Certified - 2025 Johnson & Johnson named a 2025 Fortune World's Most Admired Company Competitive salary package, flexible work practices , award winning benefits Continuous training and development ABOUT INNOVATIVE MEDICINE Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine THE OPPORTUNITY The Commercial Quality Professional is responsible for the deployment, execution, and continuous maintenance of the Product Quality Complaints (PQC) management process at Johnson & Johnson (J&J) Innovative Medicine. This role ensures full compliance with J&J Quality Policies, procedural documents, and all applicable regulatory requirements across Australia and New Zealand including managing PQCs reported in Australia and New Zealand ensuring timely reporting, investigation, and closure providing prompt and compliant responses to queries raised by Health Authorities escalating significant issues to Senior Management acting as the owner of relevant local procedural documents for Australia and New Zealand leading reporting activities, including metrics analysis and trend identification identifying, proposing, and implementing opportunities for process and system improvement The Commercial Quality Professional consistently applies J&J's Credo values and Leadership Imperatives in day-to-day interactions, fostering strong collaboration, communication, and partnership within the Commercial Quality team and with internal and external stakeholders. RESPONSIBILITIES Complaint Processing - Receive, review, log and process PQCs in accordance with regulatory guidelines and local and global standard operating procedures (SOPs). Take the lead in communication and follow-up with customer in a timely manner including provision of acknowledgement and close out investigation letters. Management and follow up of all reports with PQC implications. Manage the timely notification to the Quality leader if any cases need escalation. Manage queries from stakeholders within the J&J organisation in a timely manner. Manage the review of closure reports in a timely manner. Manage TGA & Medsafe enquiries in a timely manner with relevant internal stakeholder approval. Stability Assessments - perform stability evaluation on products involved in temperature excursions to confirm product suitability and respond to the reporter in a timely manner to ensure continuance of medication supply. Retrieval of Complaint Samples / Shipment to Manufacturer - Manage the retrieval of complaint samples and all necessary information / documentation from customers within appropriate timelines. Send complaint samples or complaint sample photographs to manufacturer for investigation. Document and file all transactions. Reconciliation - Lead and manage regular reconciliation activities within the PQC function in line with relevant SOPs. Filing & Archiving - Ensure compliant filing and archiving systems are in place for the storage and retrieval of all source documents according to local and global requirements. Procedural Documents and training - own and maintain procedural documents (SOP, WI, guidelines etc.), to ensure local compliance to global, regional and regulatory requirements. Provide trainings to internal and external stakeholders when required, and complete assigned trainings timely. Metrics and Management Reporting, Process improvements - Lead the collation and preparation of reports and Quality Management Review presentations, identify and address trends. Identify and deploy opportunities for process improvement, represent Australia and New Zealand in relevant regional and global initiatives and contribute accordingly. Audit Support - participate as an auditee in the internal and external audits and inspection including preparation of documentation for the audits and responses to audit observations (if any), deployment of corrective actions. Lead and support other activities as aligned with the direct supervisor. Required Skills or qualifications that are critical to this position Bachelor's degree in pharmacy, medical or life science Excellent verbal and written communication skills Experience in working with and managing multiple computer databases Experience in managing different stakeholders via building strong collaboration and partnership Preferred experience Experience in either Quality or Customer Service Role Experience in clinical, pharmaceutical or medical devices industries is preferable Johnson & Johnson, as a world leader across multiple therapy areas, offers a dynamic environment with opportunities to learn and grow across a broad range of those therapeutic areas. We encourage candidates with a strong desire to learn and a willingness to adapt to new challenges to apply. COMPANY CULTURE 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. WHY CHOOSE US: Competitive remuneration package and continuous training. Supportive environment with award-winning leadership development programs. Inclusive, flexible, and accessible working arrangements for all. 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 prioritize 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 was certified as a Great Place to Work® in ANZ in its first year of participation. Required Skills: Preferred Skills: Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment
