Chief Quality Officer

6 days ago

City Of Knox, Australia Medical Developments International Full time
About Medical Developments International

Medical Developments International (MDI) is a leading pharmaceutical company in Australia, renowned for its specialized products that cater to pain and respiratory needs. Our flagship product, Penthrox, has gained recognition worldwide, setting the standard for quality and innovation.

Our Core Values
  • Safety First: We prioritize patient safety above all else, ensuring our products meet the highest standards.
  • Customer Focused: We strive to deliver exceptional customer experiences, addressing their unique needs and preferences.
  • One Team: Collaboration and teamwork drive our success, as we work together to achieve outstanding results.
  • Performance Driven: We continuously push ourselves to innovate and improve, staying ahead of the curve in the industry.
  • Accountability: We take ownership of our actions, embracing transparency and responsibility in all aspects of our operations.
The Head of Quality Role

As the Chief Quality Officer, you will report directly to the CEO and play a pivotal role in the Leadership Team. Your primary responsibility will be to oversee all aspects of product, process, and systems quality at MDI. This includes:

  • Leading the Quality team, providing guidance, and ensuring they have the necessary resources to execute established procedures.
  • Collaborating with external stakeholders, including government agencies, partners, regulators, and customers, to ensure seamless communication and compliance.
  • Oversight of the API manufacturing process, formulation, filling, and secondary packing of Penthrox.
  • Responsibility for the design, development, manufacturing (through 3rd party manufacturers), and release of a range of respiratory medical devices.
Your Key Responsibilities
  1. Quality and Compliance Management: Serve as the Management Representative for Quality, ensuring GMP, ISO 13485, and relevant regulations are met.
  2. QMS Performance Reporting: Design, implement, and maintain the QMS for compliance with industry standards, reporting on performance to executive management and highlighting areas for improvement.
  3. Authorised Person for Release for Supply: Ensure products meet local/international laws and GMP, approving/rejecting materials for GMP compliance, and sourcing approved raw materials and components from qualified suppliers.
  4. Regulatory Affairs and Audits: Represent the company in certification, customer, or quality audits for both pharmaceutical and device aspects, addressing non-conformances, and implementing audits.
  5. Validation, Testing, and Auditing Oversight: Oversee validation activities (DQ, IQ, OQ, PQ), risk assessments, and protocols, ensuring equipment and premises meet GMP and QMS standards.
  6. Leadership and Process Optimization: Foster continuous improvement in quality and business objectives, driving initiatives to improve operational efficiency and profitability while prioritizing quality, and implementing process improvements to reduce waste and increase efficiency.
About You

We seek a strategic leader with a strong focus on quality and compliance. As the Chief Quality Officer, you will drive continuous improvement across MDI's quality systems, ensuring full regulatory adherence. Your ability to lead teams and optimize processes will enhance operational efficiency while maintaining the highest standards.

  • A minimum of 5 years' experience in a senior Quality Management role, preferably in the pharmaceutical and medical devices area.
  • Familiarity with global regulators and experience in an export-led business.
  • Proven experience in leading regulatory inspections, producing KPIs, reports, policies, and procedures.
  • A Degree in Science, Computer Science, Pharmacy, Engineering, or equivalent, and an additional business qualification would be considered an advantage.

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