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Quality and Compliance Officer

Mobius Medical · Australie

New
🇬🇧 English

Job description

About the role

Mobius Medical is looking for an experienced clinical research professional to join its Quality Management team as a Quality and Compliance Officer. The role focuses on maintaining and improving the Quality Management System while staying close to clinical research, without travel demands. It offers flexible hours with a minimum of 24 hours per week and a hybrid work arrangement.

Key responsibilities

  • Review, maintain, update and improve SOPs, forms, templates and controlled documents.
  • Develop and maintain SOP training support materials, including quizzes and knowledge checks.
  • Support QMS administration, document control, quality registers, QA reporting, internal audits, non‑compliance reporting and CAPA follow‑up.
  • Act as Privacy Officer: maintain privacy procedures, support risk assessments, manage incidents and promote awareness.
  • Act as Risk Officer: maintain risk processes, support project and business risk assessments and track mitigation actions.
  • Act as Safety Officer: maintain the Master Safety Database, support Safety Management Plans, SAE reporting and safety updates.
  • Collaborate with clinical operations, data management, project leads, directors and the QMS Manager to strengthen systems, training and compliance outcomes.

Required profile

  • Seasoned clinical research professional from a CRO, pharmaceutical, medical device, biotech or similar regulated environment.
  • Experience in clinical operations, quality, regulatory affairs, safety/pharmacovigilance, data management or related functions.
  • Strong understanding of clinical research and GCP; familiarity with ISO 14155 and/or ISO 9001 is highly regarded.
  • Proven experience reviewing or writing SOPs, controlled documents, training materials or compliance documentation.
  • Excellent attention to detail, written communication and organisational skills.
  • Practical, collaborative and comfortable working across teams to get actions completed.

Required skills

  • Good Clinical Practice (GCP)
  • ISO 14155
  • ISO 9001

What we offer

  • Flexible work‑from‑home and office attendance as needed (hybrid).
  • Non‑travel role that keeps you closely connected to clinical research.

Questions fréquentes

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Published 1 day ago

Expires 1 month from now

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Mobius Medical

Australie