Quality and Compliance Officer
Mobius Medical · Australie
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.
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Published 1 day ago
Expires 1 month from now
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Mobius Medical
Australie
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