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 PharmSky’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
- Robust 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.

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📌 Quality Manager - CDMO (Dandenong)
🏢 PharmSky Research
📍 Dandenong