ARAVAX: QA Manager

2 days ago

Melbourne, Victoria, Australia Fuse Recruitment Full time $80,000 - $120,000 per year

Employment Type:
Part-time (minimum 16 hours per week, with potential to increase)

Location:
Melbourne (Hybrid work options available)

Role Purpose
The QA Manager is responsible for overseeing all
GxP quality activities
across the organisation, including
GCP (clinical)
and
GMP/CMC (manufacturing)
functions. This role ensures that the company's quality systems are compliant, effective, and aligned with clinical and regulatory requirements as the organisation transitions from Phase 2 to Phase 3 clinical development.

The successful candidate will bring a practical, hands-on approach to strengthening the Quality Management System (QMS), leading compliance activities, and providing strategic and operational QA support across multiple functions.

Key Responsibilities

  • Manage and maintain the company's
    GxP Quality Management System (QMS)
    , ensuring compliance with regulatory standards.
  • Conduct a
    gap analysis
    of the current quality system and implement corrective actions where required.
  • Oversee
    day-to-day QA operations
    , including GCP and GMP activities, vendor management, and documentation control.
  • Support
    CMC quality functions
    and facilitate the transition to Phase 3 trials, including CRO selection and oversight.
  • Collaborate closely with cross-functional teams including Clinical Operations, CMC, Regulatory, and Executive Leadership.
  • Provide guidance, training, and mentorship to quality and operational staff.

Key Deliverables

  • Updated and compliant Quality Management System.
  • Gap analysis and action plan for quality improvement.
  • Defined quality processes and oversight structure for Phase 3 readiness.
  • Effective vendor and CRO quality oversight mechanisms.

Skills and Experience
Essential:

  • Minimum 10 years' experience in Quality Assurance within
    GCP, GMP, or CMC environments
    .
  • Strong understanding of
    biologics, peptides, or vaccine development
    .
  • Demonstrated experience managing or building a compliant quality system.
  • Excellent organisation, attention to detail, and problem-solving skills.
  • Science degree (Bachelor's minimum; postgraduate qualification preferred).
  • Proven leadership and stakeholder management capabilities.

Desirable:

  • Experience implementing QA software systems or digital QMS tools.
  • Prior work with allergy-related biologics or therapeutic products.

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