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Direct message the job poster from PolyNovo LimitedPeople Policy & Operations Lead @ PolyNovo Limited | LLB, MBA, HRWho We ArePolyNovo is an Australian multinational medical device company that designs, develops, and manufactures truly innovative dermal regeneration solutions, including NovoSorb Biodegradable Temporising Matrix (BTM) and MTX, using our patented NovoSorb resorbable fully biodegradable polymer technology.In the last six years, PolyNovo has grown from 40 to 300+ staff globally and has now touched the lives of over 70,000 patients. Our lifesaving and life-changing products have revolutionised the treatment of burns and major trauma as well as multiple emerging indications ,with a diverse range of medical device products in our development pipeline.With TGA, FDA, CE Mark/ MDR, Health Canada, and other registrations, our world-best polymer devices are enhancing clinical outcomes for patients around the world. See www.polynovo.com for more.About The RoleWe are seeking an experienced, strategic leader to join PolyNovo as Vice President, Quality Affairs. In this pivotal role, you will be responsible for maintaining and continually enhancing PolyNovos Quality Management System (QMS) in alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable international standards that govern the design, development, manufacture, and distribution of medical devices.As a key member of the executive team, you will ensure ongoing ISO 13485 certification and global GMP compliance with regulatory bodies, including the Therapeutic Goods Administration (Australia), the U.S. Food and Drug Administration (FDA), our EU Notified Body, and other relevant national authorities. You will provide regular reports to senior management on the effectiveness and performance of the QMS, playing a critical role in driving a culture of quality, compliance, and continuous improvement across the organisation.You will oversee our talented Quality Assurance, Quality Control, and Post-Market Surveillance teams, leading and mentoring this high-performing group of professionals and ensuring they are supported with clear development plans and empowered to deliver excellence.Why PolyNovo?Join a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry.Join our multinational, ASX-listed, values-led business dedicated to improving patient outcomes.Unique platform technology and highly innovative productsHighly motivated professional and technical teams with enviable engagement and company prideCareer development opportunities and unlimited access to online learningFlexible working arrangementsAttractive rewards platform with access to discounts at over 450 Australian retailersPaid parental leave for primary and secondary carers, Nurture Days, and moreSalary packaging, including novated car leasing.Key ResponsibilitiesLead and manage the Quality Assurance, Post Market Surveillance and Quality Control teams.Continuously review and improve the QMS to ensure it fully reflects all processes involved in designing, developing, manufacturing and distributing PolyNovos medical devices. Ensure all relevant information is reflected in PolyNovos metrics and presented at Management Review Meetings, along with its Quality Objectives.Liaise with PolyNovo staff to develop proactive strategies to mitigate risks to device safety, performance, and efficacy (whether identified through Quality meetings or otherwise), and assign action items with timeframes for completion.Liaise with accreditation bodies to prepare for audits, host regulatory audits on behalf of management, review and update the annual audit schedule and assign trained personnel specific tasks/ accountabilities to meet QMS requirements, perform internal audits/ audits of critical suppliers in accordance with the annual schedule, and ensure all action items and Corrective Actions/ Preventative Actions are closed out within prescribed timelines.Work closely with R&D, Regulatory Affairs, Clinical Research, and Production personnel to ensure that Design History Files are created for all products, including dossiers appropriately formatted for regulatory submissions. Maintain all controlled documents in accordance with documented procedures.Ensure that Batch Process Records, QC release testing, raw material/product reports, and labelling protocols are reviewed and maintained in accordance with defined manufacturing and QMS standards.Ensure the QMS Training Matrix and documentation requirements are regularly reviewed/ updated and that departmental managers actively ensure personnel are appropriately trained to perform their function and informed of their QMS responsibilities.Ensure the VMP is reviewed annually and provide guidance to the Manufacturing and R&D departments on required validation activities, and manage the Change Control process to ensure changes are appropriately risk-assessed and that any changes in device design will not impact its safety, performance or efficacy.Provide oversight on CA/PAs and investigations into non-conforming Quality-related processes such as OOS EM, raw material and QC test results, manufacturing deviations, mislabelling devices and product transport temperature excursions.Report on the suitability, adequacy and effectiveness of the performance of the QMS to the company management as the appointed Management Representative.Responsible for medical monitoring/reporting and company post-market and vigilance activities. Manage the Post-Market Surveillance team.Provide oversight on Customer Complaints/Feedback Process; ensure the Product Complaints Register is maintained with oversight and support from Regulatory Affairs. In the event of a product recall, help coordinate the Recall Team and liaise with Regulatory Affairs personnel.Other ResponsibilitiesEnsure collaborative relationships with PolyNovo team members and external stakeholders.Ensure all documentation is reviewed, current and compliant with the quality system and all responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes.Ensure behaviour is in line with PolyNovo Values.PolyNovo may require you to undertake additional responsibilities or work in other areas than those outlined in this role, subject to business requirements and your skills and competencies.About YouDegree in science, biomedical science/biotechnology, or related discipline (Masters or PhD highly regarded).At least five years experience managing Quality Assurance functions in a regulated environment, with a deep understanding of ISO 13485 and/or GMP (21 CFR 820).Proven leadership experience, with the ability to inspire, develop, and lead high-performing quality teams.Exceptional communication and interpersonal skills, with a track record of building effective relationships with cross-functional teams, external partners, and regulatory bodies.Strong project management capabilities, including budget management, forecasting, and oversight of resources such as contractors and service providers.Excellent analytical and problem-solving skills, with the ability to manage competing priorities and oversee multiple functions simultaneously.A high level of professionalism, integrity, and a commitment to maintaining the highest standards of quality and compliance.A flexible, proactive approach to work, including a willingness to travel interstate and internationally, and to work outside standard business hours if required.A solid understanding of Australian Work Health and Safety (OHS) legislation and how it applies to quality operations.Apply TodayPlease send your resume by clicking on the Apply button. Please note that, due to the high level of interest expected, only shortlisted candidates will be contacted.Learn more about PolyNovo by visiting our Website or our LinkedIn page.PLEASE NOTE ONLY APPLICANTS WITH FULL WORKING RIGHTS IN AUSTRALIA WILL BE CONSIDEREDSeniority levelSeniority levelExecutiveEmployment typeEmployment typeFull-timeJob functionJob functionQuality Assurance and ManufacturingIndustriesMedical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology ResearchReferrals increase your chances of interviewing at PolyNovo Limited by 2xGet notified about new Vice President of Quality jobs in Port Melbourne, Victoria, Australia.Melbourne, Victoria, Australia 1 week agoMelbourne, Victoria, Australia 6 days agoMelbourne, Victoria, Australia 3 weeks agoSenior Advisor, Governance and Projects (Office of the Vice President and Chief Operating Officer)Vice President - Ticketing and Concert OperationsMelbourne, Victoria, Australia 6 days agoMelbourne, Victoria, Australia 2 weeks agoMelbourne, Victoria, Australia 1 week agoWere unlocking community knowledge in a new way. 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