Senior Quality

Senior Quality & Regulatory Manager (SQRM) 15 Jul 2025 INOVIQ Ltd (ASX:IIQ) is a dynamic biotechnology company at the forefront of developing next-generation diagnostics and therapeutics for cancer. Our innovative portfolio harnesses proprietary exosome-based technologies to create advanced blood-based tests for early cancer detection, treatment selection and disease monitoring, ultimately improving patient outcomes. Additionally, our cutting‑edge extracellular vesicle (EV) therapeutic program is pioneering novel treatments for cancer, positioning INOVIQ as a leader in exosome therapeutics. We are a collaborative, innovative, and commercially driven organization, committed to excellence in research, development and product delivery. Join our passionate team and contribute to transformative advancements in healthcare. Position Overview We are seeking an experienced, proactive and detail‑oriented Senior Quality & Regulatory Manager (QRM) to join our Melbourne‑based R&D team. Reporting to the Chief Scientific Officer (CSO), you will support our innovative research and product development pipeline, clinical development and regulatory activities in Australia and internationally and lead the continuous improvement of INOVIQ’s Quality Management System (QMS). This critical role enables the successful execution of product development activities across research, preclinical and clinical studies for our diagnostic and therapeutic pipeline and ensures that our laboratory and manufacturing operations comply with global regulatory standards. As a key member of our multidisciplinary team, you will drive quality and regulatory affairs, quality standards, regulatory compliance and operational excellence across the business to ensure INOVIQ’s products meet the highest standards for quality, safety and efficacy. Key Responsibilities Quality and Regulatory Strategy: develop and execute quality and regulatory strategies for products across INOVIQ’s diagnostic, therapeutic and research tools portfolio in collaboration with senior management, R&D team and external consultants. Regulatory Submissions: Investigational Device Exemption (IDE), Pre‑Market Approval (PMA) and equivalent submissions for In Vitro Diagnostic (IVD) products to various regulatory authorities. Investigational New Drug (IND), New Drug Application (NDA) and equivalent submissions for therapeutic products, including EV‑based therapies to various regulatory authorities. Study Support: provide regulatory and quality guidance and oversight for LDT/IVD studies and IND‑enabling studies, ensuring robust program management, study design, execution, and documentation at all stages of product development. Quality Management System (QMS): design, implement, and maintain a robust QMS to support R&D and commercial activities, ensuring alignment with INOVIQ’s Quality Policy and product development goals. Accreditation and Certification: lead efforts to secure and maintain ISO17025 accreditation for laboratory competence and ISO13485 certification for medical device quality management. Regulatory Compliance: oversee adherence to current Good Manufacturing Practices (cGMP) for manufacturing processes and ensure compliance with regulatory requirements for product development and commercialization. Laboratory Excellence: ensure laboratory processes deliver accurate, reliable, and traceable results, meeting project timelines and budgetary requirements. Risk Management: implement risk‑based approaches to quality and regulatory processes, proactively identifying and mitigating potential issues. Collaboration: work closely with cross‑functional teams, including R&D, manufacturing, clinical operations and commercial, to foster a culture of quality, innovation, and accountability. Continuous Improvement: drive initiatives to enhance quality systems, streamline processes, and maintain compliance with evolving regulatory standards. About You Experience: Minimum of 5 years’ experience in quality and regulatory affairs within the biotechnology, pharmaceutical or medical device industry, with a proven track record of implementing QMS and achieving quality and regulatory objectives. Technical Expertise: In‑depth knowledge of ISO17025, ISO13485, cGMP and FDA regulatory pathways (PMA, CE‑IVD, IND, NDA). Experience with global regulators and their frameworks (e.g., FDA, EMA, TGA) is highly desirable. Skills: Exceptional attention to detail and organizational skills. Strong analytical and problem‑solving abilities, with a focus on risk management and continuous improvement. Excellent communication and interpersonal skills to collaborate effectively with internal teams and external stakeholders. Ability to manage multiple priorities in a fast‑paced, innovative environment. Qualifications: Bachelor’s degree in a relevant scientific or technical field (e.g., biotechnology, biomedical engineering or related discipline). Advanced degrees or certifications (e.g., RAC, CQM) are advantageous. Personal Attributes: Proactive, results‑oriented, and self‑motivated, with a passion for advancing healthcare through quality and innovation. Why Join INOVIQ? Impactful Work: contribute to groundbreaking diagnostics and therapeutics that improve patient lives. Innovative Environment: be part of a collaborative, forward‑thinking team pushing the boundaries of exosome technology. Career Growth: opportunity to grow within a rapidly expanding ASX‑listed company with a global vision. Competitive Package: attractive salary, performance‑based incentives and a supportive work culture. How to Apply Interested candidates should submit their resume and cover letter outlining relevant experience and qualifications to by 15 August 2025. Please Note Only shortlisted candidates will be contacted. INOVIQ Ltd is an equal opportunity employer committed to diversity and inclusion. #J-18808-Ljbffr