Are you an experienced CQV Quality professional looking to lead complex projects in a dynamic, evolving GMP manufacturing environment?
We are partnering with a global biopharmaceutical organisation to recruit a Quality Projects Lead on a two-year fixed term contract to support a major site transition and capital program at their Melbourne manufacturing site. This is a hands‑on, delivery‑focused role with a strong emphasis on Commissioning, Qualification, and Validation (CQV) across facilities, utilities, and equipment.
The role sits at the centre of multiple concurrent projects and will be instrumental in establishing CQV frameworks, ensuring inspection readiness, and maintaining compliance while project timelines move at pace.
Key Responsibilities:
- Provide quality leadership across site projects with a strong focus on CQV execution and oversight.
- Lead and support commissioning, qualification, and validation activities, including hands‑on review and approval of FAT, SAT, IQ, OQ, and PQ documentation, validation strategies, and master plans.
- Embed quality into project workstreams by partnering closely with Project Managers, Engineers, Operations, and Technical SMEs.
- Define regulatory approval pathways, inspection readiness strategies, and quality milestones aligned to project timelines.
- Establish and maintain CQV tracking, governance, and reporting to manage large volumes of qualification documentation.
- Provide pragmatic guidance to project teams, balancing delivery pressure with regulatory and GMP compliance requirements.
- Support deviation, change control, and risk management activities arising from project execution.
To be considered for this role, you will have the following qualifications and skills:
- A Bachelor’s degree in Science, Engineering, or a related discipline.
- Solid hands‑on commissioning, qualification, and validation experience in the pharmaceutical or biotech industry.
- Proven experience working in GMP environments within pharmaceutical or biologics manufacturing
- Sound working knowledge of Australian GMP, PIC/S, Annex 1, and contamination control principles.
- Confidence working in evolving project environments with limited structure, ambiguity, and changing priorities.
- Strong stakeholder management skills with the ability to challenge timelines diplomatically when compliance is at risk.
- A proactive, self‑managed approach with the willingness to seek information and drive outcomes.
This is an ideal opportunity for a validation professional who enjoys autonomy, variety across multiple projects, and the chance to help shape CQV practices from the ground up while contributing to a critical site transition program. For a confidential conversation about this role, please email gbitodi@onqrecruitment.com.au.
