Quality Manager - CDMO in Dandenong

We are seeking an experienced Quality Manager with a can-do, results-driven attitude to lead and continuously improve our Quality Management System, ensuring compliance with the GMP and global regulatory frameworks, including TGA, PIC/S and international quality standards.

Our ideal candidate will be a highly motivated, hands-on key member of the Quality & Regulatory team who is adept to working in a fast-paced, collaborative environment within a small team, contributing to the efficiency of our daily operations.

Key responsibilities

• Quality Management System
• Continuously drive improvements of the QMS ensuring alignment with TGA, PIC/S and other global regulatory requirements.
• Define and monitor quality performance through metrics and governance processes.
• Own document control: review and approve SOPs, protocols, and other controlled documents with the relevant Area Managers.
• Implement quality risk management strategies and lead the resolution of quality issues including deviations, CAPA, OOS/OOT investigations, product quality complaints, recalls, making sure each is closed out in a timely manner.
• Ensure timely communication and escalation of quality issues to management.
• Batch certification and release
• Act as an Authorised Person for certification and release of investigational medicinal products (IMPs).
• Qualification and validation
• Review and approve qualification and validation programs for facilities, equipment and processes.
• Licences, inspections and audits
• Maintain Pharm Sky's GMP licences and related permits,
• Act as the point of contact for all TGA correspondence, including application for licence variations, and audits.
• Define, lead and prepare for internal audit programs and host client and regulatory audits.
• Suppliers and clients
• Conduct vendor assessments, qualification and audits, and approve and monitor providers of outsourced GMP activities.
• Establish and maintain Quality Agreements with suppliers and clients.
• Support Business Development and Project Management with quality input to client projects, proposals and timelines.
• Regulatory support
• Ensure phase-appropriate regulatory requirements are met for development programs.
• Support regulatory submissions and client CMC documentation.
• Training and culture
• Provide or organise staff training on GMP principles and the QMS and maintain training records.
• Uphold and champion a strong quality culture across the business.
• Workplace and WH&S
• Follow company policies, treat others with respect and lead by example.
• Follow safe working procedures, use PPE as required, and report hazards, near misses and incidents promptly.
• Key selection criteria
• Bachelor's degree or higher in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy, Engineering or a related life science.
• At least 8–10 years' experience in the pharmaceutical, biotech or medical device industry, including at least 5 years in a GMP quality role.
• Experienced in maintaining a QMS: document control, change control, deviations, CAPA and audits.
• Current knowledge of GMP and global regulatory frameworks, including TGA and PIC/S requirements, including Annex 13 (Investigational Medicinal Products).
• Experience in regulatory inspections and client audits.
• Demonstrated expertise in quality risk management
• Strong problem-solving, organisational and written communication skills, with the ability to manage multiple priorities.
• Full working rights in Australia.
• Experience as, or eligibility to act as, an Authorised Person for batch release.
• Pharmaceutical sterile manufacturing experience and working knowledge of PIC/S Annex 1 and contamination control strategies.
• Experience in a CDMO and/or contract testing environment.
• Familiarity with FDA, EMA and ICH guidelines and regulatory submissions.
• Experience as Responsible Person for Drugs, Poisons and Controlled Substances licences.
• Personal attributes
• Leads by example and upholds GMP standards.
• Practical and hands-on, comfortable in an informal, fast-paced small team.
• Builds good working relationships with colleagues, clients, suppliers and regulators.
• Continuously seek improvements to quality systems and ways of working.