Associate Director, BioNTainer Australia, Technical QA
Core
Establish and develop the Technical Quality Assurance (QA) organization and processes for a modular mRNA manufacturing site (BioNTainer) in Australia, ensuring GMP compliance for manufacturing and QC activities.
Role type
Senior leadership Technical QA Manager (Associate Director level)
Builds
Modular mRNA manufacturing facilities and regional manufacturing networks
Domain
Biotechnology / mRNA therapeutics / Pharmaceutical Manufacturing
Required skills
GMP compliance, Technical QA strategy, Team leadership, Process validation, Regulatory inspections, Documentation authoring, Quality metrics management
Preferred skills
Sterile dosage forms, RNA/biologics production, TGA/PIC/S regulations, ICH/FDA/EMA guidelines, Technology transfer
Technologies
GMP systems, Validation tools, Quality management software
Responsibilities
Establish Technical QA structure for Manufacturing and QC, Lead and mentor the Technical QA team, Provide technical QA input for equipment setup and validation, Author GMP-compliant documentation and SOPs, Develop and manage Quality metrics, Support regulatory submissions and audits
Seniority
Senior, hands-on IC with management responsibilities