QA Tech Ops Lead — GMP Validation & Tech Transfer

Moderna

City of Melbourne

On-site

AUD 120,000 - 170,000

Full time

14 days+
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Benefits offered by this job

Healthcare benefits
Well-being programs
Family building benefits
Generous paid time off
Year-end discretionary shutdown

Job summary

Moderna is expanding its Melbourne Quality team to ensure quality, compliance, and technical excellence across mRNA manufacturing operations.

You will collaborate with cross‑functional teams, applying risk‑based QA decisions to support validated states and regulatory readiness. The role emphasizes validation, technology transfer, and continuous improvement in a fast‑paced environment.

Qualifications

  • Bachelor's degree in science or engineering or equivalent experience.
  • 5+ years of pharmaceutical quality, validation, or GMP experience.
  • Experience with equipment qualification and process validation in GMP settings.
  • Experience handling deviations, investigations, CAPAs, change controls, and risk assessments.
  • Experience supporting QC laboratory validations, investigations, and escalation in GMP environments.
  • Strong technical writing for GMP/validation documentation.
  • Cross-functional communication and audit/inspection support.

Responsibilities

  • Provide quality oversight across manufacturing, validation, and QC activities, incl. equipment and method validation.
  • Oversee commissioning, qualification, and validation of equipment, systems, facilities, and utilities.
  • Support validation lifecycle activities: PPQ, CPV, and changes affecting validated state.
  • Lead or support QC laboratory validation activities and related investigations.
  • Act as QA escalation point for technical, operational, validation, and QC issues.
  • Review and approve GMP documentation and validation reports to ensure compliance.
  • Support product technology transfers and validated processes across operations.

Skills

Quality Oversight
Validation
GMP Experience
Deviation Investigations
Change Controls

Education

Bachelor's degree in science/engineering

Job description

Moderna is expanding its Melbourne Quality team to ensure quality, compliance, and technical excellence across mRNA manufacturing operations.

You will collaborate with cross‑functional teams, applying risk‑based QA decisions to support validated states and regulatory readiness. The role emphasizes validation, technology transfer, and continuous improvement in a fast‑paced environment.

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