Quality Systems & Compliance Manager
Position Overview
- Ongoing| Full Time | $129- $144k +15.4% super
- Work-life balance | Free onsite Parking | Health & Wellbeing Programs | Sporting Facilities
- On-site Childcare for employees | Work in a campus-based community environment | Cafe on site
- Looking for someone with experience with management of quality systems & end-to-end GMP manufacturing experience?
About the Opportunity
The Quality Systems & Compliance Manager manages the quality system functions of 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:
- Developing and maintaining the licensed state to manufacture both finished goods and APIs through oversight of the Pharmaceutical Quality System (PQS) with established standards and agency guidelines to ensure compliance.
- Ensuring a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards, and business needs.
- Manage quality systems inclusive of management of change (MOC), corrective actions and preventative actions (CAPA), audits, document management, deviations, supplier management, out of specification-tolerance(OOS-OOT), Product Quality Review (PQR), customer complaints, and sterility assurance.
- Management of validation schedule ensuring compliance for process, equipment, and computer systems
- Management of Sterility assurance ensuring regulatory compliance
About You
"We are looking for a highly motivated and passionate Compliance professional who has experience in end-to-end GMP manufacturing. The ideal candidate will have experience in management of quality systems, a good understanding of qualification and validation requirements and understands the compliance obligations for Sterility Assurance." - Ivan Siladji, Head of Quality
Your Duties and Responsibilities
- Managing all quality systems for Nuclear Medicine
- Monitor and report on all quality metrics and trends
- Manage qualification and validations to ensure all compliance expectations are met
- Subject matter expert for sterility assurance and determine continuous improvement initiatives
- Lead education programs for compliance requirements across relevant facilities
- Oversee transition to revised PIC/s Code to GMP Annex 1
Please click here to view the Position Description.
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.
Benefits of Working with Us
ANSTO employees are passionate about what they do. We enjoy being part of an organisation making a difference in the lives of Australians.
We support and reward our employees through eligibility for:
- Training, development and mentoring opportunities
- Performance based salary increases
- Work-life balance with generous leave entitlements and flexible conditions
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 or contact Lee-Ann Carrasco on (+61) 476 246 149. 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: 04 November 2024 at 11:59pm
All applicants mut 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.