AddressAbout Us
Our vision is Exceptional Science, Healthier Lives.
The Translational Research Institute (TRI) is a leading Australian innovative medical research, development and translation facility. As an institute focused on research translation, TRI is charged with partnering scientific development with the commercial sector to ensure innovations move rapidly to improve patient outcomes and commercial return. To this end, TRI is at the interface of science, medicine and industry. One of the key foundation catalysts was the international adoption of Gardasil, a cervical cancer vaccine, one of Australia's most successful examples of translational research.
In 2022, TRI has been funded to build a new facility adjacent to the Princess Alexandra Hospital / TRI campus which will be known as Translational Manufacturing at TRI (TM@TRI). This facility will be the home of MedTech start-up/scale-up companies to support GMP manufacturing for novel products to support Phase I-III clinical trials.
Our Benefits include:
- Competitive salary
- Opportunity to salary sacrifice superannuation & access to novated Leasing through Orix
- 17.5% Annual Leave Loading
- Training and development opportunities
- A focus on staff engagement and employee wellbeing. We have a well-being committee that focuses on strengthening and supporting the wellbeing of it's community
- Access to EAP services
About the Role
The Quality Assurance Manager (cGMP) is responsible for leading and establishing an independent Quality team, designing, and implementing a fit for purpose Quality Management System (QMS) and providing QA oversight on all commissioning, qualification, and validation (CQV) activities, ensuring the successful delivery of the new TM@TRI cGMP facility. Post commissioning of the TM@TRI facility, this role will provide overarching Quality oversight ensuring the TM@TRI facility is maintained in a compliant cGMP state and sustain the QMS governing all facets of cGMP Operations.
Key Selection Criteria
Qualifications
- Relevant technical qualifications and/or extensive experience in a cGMP environment.
- Tertiary qualifications (or equivalent) in science or a field related to the operational management of TM@TRI.
Experience
- Proven track record in the design of and start-up of Quality management systems and cGMP facilities.
- Experience overseeing and managing cGMP environmental monitoring, testing and reporting programs.
- Experience drafting and managing cGMP Quality Agreements.
- Significant regulatory experience across different modalities (e.g. med-tech, diagnostic, large molecule manufacturing).
- Experience achieving results through other people, people development and management.
- Significant experience in leading cross-functional teams, developing strategies and goals, and delivering successful outcomes.
- Developed communication and interpersonal skills, ability to negotiate, consult, manage change, and engage with a diverse range of groups internally and externally.
- Ability to develop strong and effective working relationships to create innovative solutions.
Technical Knowledge
- Extensive operational knowledge of the cGMP environment.
- Experience in program delivery and relationship management.
- A good understanding of relevant QMS and other accreditations an advantage
- Self-driven, Autonomous
- Ability to act independently and take initiative without direction within established TRI policies and guidelines.
To apply for this position, candidates must submit a cover letter addressing the selection criteria and a current resume quoting job reference 1752.
Applications close at 5:00 pm Monday, 3 June 2024. Please note, candidate applications will be reviewed when received and considered for interview prior to ad closing.
