Pharmaceutical Quality Oversight at Moderna

Setup: Hybrid
Location: Melbourne, Victoria
Type: Full-time

Description

Moderna is seeking a Pharmaceutical Quality Specialist to oversee quality assurance across various aspects of manufacturing operations, technology transfer, GMP facility initiatives, and QC laboratory support. The role involves providing quality oversight for drug product validation, including equipment and process qualification, lifecycle management, and analytical method validation. The specialist will ensure scientific soundness, inspection-readiness, and alignment with quality system requirements, acting as a key quality partner to various departments.

Required Skills

Pharmaceutical Quality Oversight
Equipment Qualification
Process Validation
Lifecycle Validation Management
Analytical Method Validation
Risk Management Principles
Technical Writing
Cross-functional Communication Skills

Additional Information

Required Previous Experiences: 5+ years of pharmaceutical quality, validation, or related GMP experience.
Experience with equipment qualification, process validation, and validation lifecycle management in a GMP-regulated environment.
Experience with deviations, investigations, CAPAs, change controls, and risk assessments.
Experience supporting QC laboratory validations, investigations, and escalation in a GMP-regulated environment.
Preferred Qualifications: Experience supporting sterile drug product manufacturing.
Experience with process performance qualification, continued process verification, and drug product equipment qualification.
Experience supporting QC laboratory equipment qualification and GMP laboratory quality systems.
Experience applying formal quality risk management methodologies to process, equipment, system, or laboratory changes.
Experience supporting technology transfer, startup, or commissioning in a highly regulated manufacturing environment.