Quality Manager, Nsw Tissue Bank Bioengineering Project

Employment Type: Temporary Full Time (until June 2028)
Position Classification: Health Manager Level 3
Remuneration: $122,850 - $139,559 per annum plus superannuation
Hours Per Week: 38
Requisition ID: REQ462680
Are you highly motivated; take pride in excellence and enjoy the challenge of working in an exciting and innovative team? Come and join the NSW Organ and Tissue Donation Service.
Where you'll be working
The NSW Organ and Tissue Donation Service (NSW OTDS) is the state-wide NSW Health agency responsible to save and improve the lives of more Australians through optimising every potential organ and tissue donation for transplantation. Our objectives are to:

• Optimise organ and tissue donation opportunities for transplantation
• Provide specialist support for families involved in the donation process
• Increase consent through registration (on the Australian Organ Donor Registry) and family discussion
• Enhance systems to support donation and transplantation.

The NSW OTDS is hosted by the South Eastern Sydney Local Health District (SESLHD).
What you'll be doing
The OTDS is a partner in the BIENCO Consortium which has received $35 million to develop new technologies to prevent and treat corneal blindness. The BIENCO consortium brings together clinicians, engineers, researchers and management expertise from Centre for Eye Research Australia (CERA), NSW Organ and Tissue Donation Services (NSW OTDS), Queensland University of Technology (QUT), University of Melbourne (UoM), University of Sydney (USyd) and the University of Wollongong (UoW) to produce a bioengineered cornea for clinical evaluation within 5 years. BIENCO is addressing a global market need for bioengineered corneas and the development a world class platform and capabilities in tissue engineering, human collagen production and cGMP manufacture.
The OTDS is responsible for the overall governance and day to day management of the consortium and its stakeholders, leading the registration of the products and components as well as the establishment of GMP laboratory facilities for manufacture of BIENCO products.
New positions are being established at the OTDS to guide the manufacturing and regulatory pathways of products at the development stage as well as establish a Code of Good Manufacturing Practice (cGMP) Framework across all projects and implement a Plan for compliance with the Therapeutic Goods Administration’s (TGA) cGMP. A Quality Plan will be developed for each product through a centralised system to ensure consistency and integration when developing the whole cornea. This will ensure ongoing quality and regulatory requirements are identified, addressed, and coordinated throughout the development and commercialisation of the BIENCO products. The overarching BIENCO cGMP Plan will include a risk management plan as well as document, equipment, materials and supplier management.
The Manufacturing Quality Lead will lead and coordinate product quality and manufacturing compliance activities across consortium partners. This is an extremely exciting opportunity to be part of world leading biotech developments, please reach out if you are interested in discussing any of the roles.

• Relevant tertiary qualifications or equivalent work experience, or a combination of study and work experience.
• Demonstrated sound knowledge and/or experience with quality management systems used to review and monitor an organisation's performance
• Demonstrated experience working within the regulatory and legislative frameworks for registered therapeutic goods within Australia or equivalent.
• Demonstrated high level written and verbal communication, interpersonal and influencing skills with experience in project management and change control.
• Demonstrated ability to develop and maintain effective working relationships with senior management, colleagues and stakeholders and experience in service level and strategic planning.
• Demonstrated high level analytical and problem-solving skills including the ability to provide authoritative advice and recommendations across a large and complex organisation.
• Effective time management skills and demonstrated ability to prioritise and meet conflicting deadlines.

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For role related queries or questions contact Danielle Fisher - Danielle.Fisher1@health.nsw.gov.au
Applications Close: Sunday 11th February 2024 11.59 pm