Quality Assurance for Quality Control, Australia

Providing QA oversight of QC systems, laboratory controls, documentation, data integrity, and computerised systems (e.g., LIMS, CDS, eLN), ensuring full ALCOA+ compliance.,Supporting analytical method lifecycle management including qualification, validation, and transfer in line with ICH Q2(R2), USP/Ph. Eur., FDA, TGA and EMA expectations.,Leading QA oversight of QC microbiology operations including environmental monitoring, clean utilities, and contamination control alignment with global strategy.,Ensuring GMP compliance in all QC activities, including review and approval of SOPs, APQRs, reports, and technical protocols.,Conducting risk-based assessments under ICH Q9 for decision-making and prioritisation of QA oversight.,Driving lab readiness for TGA and other global health authority inspections, leading preparations, walkthroughs, and audit response.,Overseeing Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation investigations with an emphasis on timely escalation, CAPA effectiveness, and scientific justification.,Supporting oversight of external/contract laboratories globally, including qualification, auditing, and quality agreement governance.,Coaching and guiding QC staff through QA lab walkthroughs, real-time data reviews, and training support.,Maintaining robust oversight of stability programs and lifecycle management of reference standards, critical reagents, and working materials.,Ensuring all personnel adhere to GDP, Data Integrity, and training requirements, with comprehensive documentation practices.,Performing QC data trending and analysis to identify risks, drive process improvements, and ensure data-driven decision-making.,Aligning QC oversight strategies with other Moderna manufacturing and testing sites to ensure consistency and shared learning.,Participating in or supporting global analytical initiatives involving generative AI tools to enhance QC performance and digitalisation opportunities.,Managing timely escalation of compliance risks to site and global Quality leadership.,Bachelor's Degree in a scientific field.,7 years of Biopharmaceutical / Pharmaceutical Industry experience.

Strong working knowledge of cGMP regulations, ISO standards, and other relevant regulatory guidance documents.,Experience with regulatory inspections as a Subject Matter Expert (SME), including direct interactions with worldwide health authorities.,Demonstrated experience in analytical or microbiological method validation.,Experience with OOS/OOT investigation management, risk management, and digital quality systems.,Strong leadership skills with ability to develop, mentor, and motivate diverse teams.,Excellent project management, organizational, and communication skills.,Demonstrated ability making risk-based decisions.

Bachelor's Degree in a scientific field

May be subject to pre-employment and periodic medical assessments.,Occasionally participating in shift coverage or on-call rotations where required.