Head of Regulatory Compliance

5 days ago

City of Knox, Australia Medical Developments International (MDI) Full time
Job Description
  • Quality and Compliance Management
    • Serve 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 Oversight
    • Oversee 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 Optimization
    • Lead 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.

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