Quality Manager – QMS, Systems Compliance & Continuous Improvement
Core
Lead the Quality Systems team to oversee, drive compliance, and evolve the Quality Management System (QMS) for a next-generation microarray patch delivery platform.
Role type
Senior Quality Manager (QMS & Continuous Improvement)
Builds
Scalable, compliant Quality Management Systems and digital quality initiatives for a biotech vaccine delivery platform.
Domain
Biotechnology / Vaccines / Regulated Manufacturing
Required skills
Quality Management System (QMS) leadership, GMP compliance, electronic Quality Management Systems (eQMS) implementation, quality risk management, continuous improvement, change management, stakeholder engagement, team mentorship, audit management.
Preferred skills
Aseptic manufacturing experience, GLP/GMP/ISO 13485 knowledge, regulatory framework experience (TGA/FDA/MHRA/EMA), validation of manufacturing processes/equipment/computerised systems, clinical study GMP knowledge.
Technologies
eQMS platforms, validation tools, audit management systems
Responsibilities
Lead and mentor the Quality Systems team; drive QMS effectiveness and continuous improvement; champion eQMS implementation; ensure compliance with GMP and regulations; partner with cross-functional teams on quality challenges; participate in internal, supplier, and external audits; drive quality culture and cultural change initiatives.
Seniority
Senior, hands-on IC with leadership responsibilities
