Direct message the job poster from Medical Developments International (MDI)Medical Developments International (MDI) is one of Australias leading specialised pharmaceutical companies with an industry-leading range of products in areas of pain and respiratory. Most notably, our lead pain relief product, Penthrox, is widely known here in Australia and is sold throughout the world.At MDI, everything we do is guided by our core values:Safety First, Customer Focused, One Team, Performance Driven, and Accountability. These principles shape how we work together, serve our customers, and achieve outstanding results.We are driven to continuously innovate and create meaningful value in all we do to improve patient experience and outcomes. We value the uniqueness and diversity of our employees and recognise that nurturing the diverse perspectives and strengths of our people translates into better patient care.About the RoleThe Head of Quality reports directly to the CEO and is a member of the Leadership Team. This position has overall accountability for all aspects of product, process and systems quality at MDI. This includes but is not limited to responsibility for the effective leadership of all Quality staff, and as the principal point of contact for all quality matters with external stakeholders, including government, partners, regulators and customers.As the Head of Quality you will be responsible for oversight of the API manufacturing process, formulation, filling and secondary packing of the Penthrox drug. In addition, you will have oversight of the design/development, manufacturing (through 3rd party manufacturers) and release of a range of respiratory medical devices. This is a unique opportunity to lead a RX and Medical Device Quality team.Your key responsibilities will be but are not limited to:Quality and Compliance ManagementServe as the Management Representative for Quality, ensuring GMP, ISO 13485, and relevant regulations are met. Design, implement, and maintain the QMS for compliance with industry standards.Report on QMS performance to executive management, highlighting areas for improvement and ensuring awareness of regulatory requirements across the business.Act as the Authorised Person for Release for Supply, ensuring products (Drug Substance, Drug Product, Finished Product) meet local/international laws and GMP. Approve/reject materials for GMP compliance.Ensure sourcing of approved raw materials and components from qualified suppliers, verifying that all goods meet required quality standards.Represent the company in certification, customer, or quality audits for both pharmaceutical and device aspects. Address non-conformances and implement audits.Maintain quality systems per FDA (21 CFR 820) and GMP guidelines.Validation, Testing, and Auditing OversightOversee validation activities (DQ, IQ, OQ, PQ), risk assessments, and protocols, ensuring equipment and premises meet GMP and QMS standards.Approve test specifications, sampling instructions, and test methods. Oversee testing (raw materials, in-process, finished products) and review results for compliance.Approve or reject materials, products, and production records, ensuring compliance with GMP. Investigate and resolve errors in production records.Monitor contracted staff and ensure third-party services/products comply with GMP standards.Oversee equipment installation, maintenance, calibration, and ensure systems remain validated.Ensure batch manufacture complies with approved methods, GMP, QMS, and regulatory standards.Leadership and Process OptimizationLead and mentor the Quality team, ensuring proper training and resources for established procedures. Foster continuous improvement in quality and business objectives.Drive initiatives to improve operational efficiency and profitability while prioritizing quality. Implement process improvements to reduce waste and increase efficiency.Lead or participate in change management, including corporate strategic plans. Standardize measures to enhance transparency, results visibility, and collaboration.Collaborate cross-functionally to align quality and operational goals, engaging in problem-solving to improve the quality management strategy.About YouYou are strategic, with a strong focus on quality and compliance. With a proactive approach and exceptional analytical skills, youll drive continuous improvement across MDIs quality systems, ensuring full regulatory adherence. Your ability to lead teams and optimize processes will enhance operational efficiency while maintaining the highest standards. As a trusted authority in quality assurance, youll balance technical expertise with leadership, empowering teams to meet MDIs goals and uphold product integrity. You also possess the ability and appetite to be an enterprise leader, contributing to discussions and offering viewpoints on all facets of our business.It is essential that you have:Experience in the pharmaceutical and medical devices area in GMP manufacturing compliance.Familiarity with global regulators and ideally deep experience in an export led business.Proven experience in leading regulatory inspections.Demonstrated written abilities to produce KPIs, reports, policies and procedures.Proven ability to motivate and lead a team of managers and staff to manage quality services.A Degree in Science, Computer Science, Pharmacy, Engineering or equivalent.An additional business qualification would be considered an advantage.At least 5 years in a senior Quality Management role.What do we offer?At MDI, we will offer you:a competitive salary and short-term incentives that reflects your skills and experienceopportunities for professional development and growtha friendly and supportive team environmentMDI Anniversary Leave - 1 extra day off to celebrate your time with us!For this exciting opportunity, apply now!Seniority levelExecutiveEmployment typeFull-timeJob functionQuality AssurancePharmaceutical Manufacturing #J-18808-Ljbffr
Job Title
Head of Quality