Quality Assurance Manager - Operations

Position Overview

• Ongoing | Full Time | $133k - $149k +15.4% super | salary sacrificing available
• Onsite Childcare for Employees | Cafe on site  | generous leave provisions
• Sutherland Shire location I Health & Wellbeing Programs I bus from Sutherland Station
• Looking for a Quality Assurance & Compliance professional who has experience in end-to-end GMP manufacturing.

About the Opportunity

The Quality Assurance Manager manages the Quality Assurance functions of ANSTO Nuclear Medicine to ensure compliance with the requirements of the TGA licence to manufacture therapeutic goods, Nuclear Medicine Product Quality System (PQS) and other regulatory requirements.  This includes:

• Manage overall authorisation of release for supply and second stage release of finished goods and API.
• Provide Quality leadership to cross-functional teams working on FMEA, root cause analysis, and other investigative tools to ensure a holistic and systemic quality approach is imbedded in everything we do.
• Quality oversite for Risk assessment system
• Triage of facility and manufacturing events ensuring the safe supply of nuclear medicine products from Lucas Heights campus whilst maintaining regulatory compliance.

About You

We are looking for a highly motivated and passionate Quality Assurance and Compliance professional who has experience in end-to-end GMP manufacturing. The ideal candidate will have experience in management of quality systems, release for supply as an authorised person, a good understanding of facility control and sterility assurance." - Lee-Ann Carrasco, Head of Quality

Your Duties and Responsibilities

• As a manager and product quality expert, lead and develop staff to ensure a depth of technical knowledge within Nuclear Medicine.
• Driving the transformational quality culture initiatives across the site by liaising with cross functional teams. Embed quality processes into all facets of manufacture through the quality on the floor program. Provide Quality leadership to cross-functional teams working on FMEA, root cause analysis, and other investigative tools to ensure a holistic and systemic quality approach is imbedded in everything we do.
• Conduct regular evaluation of quality product systems including analysis of changes in legislation, nuclear medicine policies, procedures, training, and communication.
• Manage overall release for supply and second stage release of starting material, intermediates, finished goods and API in accordance maintaining current regulations whilst meeting operational and customer requirements.
• Management of the investigation of operational component of non-conformances, including key participation in the identification and raising of issues, root cause analysis, identification, and implementation of corrective and preventative actions

Please click here to view the Position Description or click Apply to View.

About Us

ANSTO leverages great science to deliver big outcomes.  We partner with scientists and engineers and apply new technologies to provide real-world benefits.  Our work improves human health, saves lives, builds our industries and protects the environment.  ANSTO is the home of Australia's most significant landmark and national infrastructure for research.  Thousands of scientists from industry and academia benefit from gaining access to state-of-the-art instruments every year.
 

Working with us you will enjoy

ANSTO offers training and development, performance based salary increases and an extensive range of leave provisions to help employees balance work and personal commitments.

• 18 days personal/carers leave for each year of service
• 3 days paid leave between Christmas and New Year
• Generous parental leave provisions:
• 18 weeks Parental leave for primary caregiver
• 11 weeks Parental leave for secondary caregiver (with incremental increase to a maximum of 18 weeks effective 01/03/2027)

• Annual flu vaccinations
• Cultural, Naidoc and First Nations ceremonial leave

If you want to join a world class organisation that's making a difference in the lives of Australians, apply now!

How to Apply

For further technical information relating to this position please refer to the Position Description.  For all other queries please contact Talent Acquisition on +61 (02) 9717 9361

To be eligible for appointment, applicants will require a security and pre-employment medical assessment.

Application closing date:  11:59am 6 July 2025

All applicants must be Australian citizens.

In order to solve great challenges, we need great minds and great teams. At ANSTO, we understand that diverse teams produce better outcomes and we value the merit that a diverse perspective can bring to our team. We encourage people from diverse backgrounds to apply for our roles including Aboriginal and Torres Strait Islander people, primary carers, those with a disability, and women in STEM. ANSTO is a charter member of the Science in Australia Gender Equity (SAGE) initiative and is proudly taking action to create a gender-inclusive workforce.