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Senior Quality Associate
2 weeks ago
ImmVirX Pty Ltd (ImmVirX) is a privately funded biotech company with a research agreement in place with The University of Newcastle Research Associates (TUNRA). Under the collaboration TUNRA employs and provides a Research & Development (R&D) team and facilities to ImmVirX on an exclusive basis. This role will join the TUNRA team working exclusively on the ImmVirX project at the Hunter Medical Research Institute (HMRI) in Newcastle.
The Senior Quality Associate will work to support the program across the broad spectrum of ImmVirX's oncolytic immunotherapy pipelines which includes activities in manufacturing, pre-clinical, clinical, regulatory, and general operations ensuring quality across the company. These activities are conducted both in-house at its Newcastle facility and through outsourced vendor arrangements.
The role supports Chemistry, Manufacturing, and Control (CMC) activities, including in-house manufacturing and quality control testing. It also encompasses document management for clinical trials and sample analysis; GxP vendor qualification and oversight; as well as active maintenance of the Quality Management System (QMS).
This role reports to the Director of Quality Management and has no direct reports.
Duties and Responsibilities
- Support all manufacturing activities including batch record collection and batch reviews.
- Development, management, and implementation of the QMS spanning R&D activities, product development and commercialisation activities for our oncolytic immunotherapy products.
- Manage GxP vendor qualification, audits and reviews.
- Facilitate investigations, deviations and CAPAs within the QMS. This may include quality-related issues with external CMO, CRO, clinical sites and shipments.
- Manage quality related clinical product distribution procedures, including review of temperature excursions.
- Cover all necessary GxP activities; especially GMP.
- Support the regulatory team with documentation and QC reviews.
Required Skills and Experience
- Degree in in biological/biomedical sciences, pharmacy degree or comparable.
- At least 3 years' quality management experience in the pharmaceutical/biotechnology industry is essential.
- Experience within GxP; and especially the cGMP environment
- Strong English language skills - verbal and written
- Superior level of skill and attention to detail regarding editing and manipulating documents (e.g. hyperlinking within document, formatting, referencing, etc).
- Superior organisational skills
- Excellent time management skills
- Team player, but also able to work independently
- Adaptable/flexible
Desired skills and experience:
- Experience with pharmaceuticals and specifically oncolytic virus is a significant advantage
- Prior experience supporting regulatory submissions
- Experience in supporting CMC activities
- Experience with management of clinical trial samples
- Experience working in a small sized biotechnology company
This role is ideally full-time, but applications for part-time work will be considered.
Please submit all applications through Seek.
The closing date for applications is
Sunday 28th September 2025.
