Operational Quality Assurance Manager

4 weeks ago

Lucas Heights, Australia ANSTO Full time

**Position Overview**:

- Ongoing | Full Time | $124k - $138k +15.4% super | generous leave provisions
- Sutherland Shire location I Health & Wellbeing Programs
- Free onsite parking | Work in a campus-based community environment
- Opportunity to lead and drive the full capability of a quality assurance team in the dynamic nuclear medicine industry

**About the Opportunity**:
The Operational Quality Assurance Manager role leads the QA function with a strong focus on driving quality across all operational activities. Reporting to the Head of Quality, Nuclear Medicine, you will be working closely with key stakeholders and other members of the management team and will be responsible for ensuring compliance with the requirements of the TGA licence to manufacture therapeutic goods and managing the direction and performance of Product Quality Reviews (PQRs), OOS/OOT investigations, deviations, product release, product recall coordination, customer complaint investigations, and embedding “quality on the floor” with a high performing QA team.

**About You**:

- "Success in this role will see you bring an organised, efficient, and structured approach to managing and leading a quality assurance function, underpinned by a strong foundation across all aspects of GMP within regulated environment. A people first approach to quality management centred around building relationships across the business will serve to embed a robust quality culture."_ - **Ivan Siladji, Head of Quality, Nuclear Medicine**

**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
- Participate in regulatory and external audits for operational compliance and provide technical knowledge and documentation. Develop audit responses and lead implementation of operational quality corrective and preventative actions. Provide technical information and operational quality assurance information for customer enquiries and regulatory submissions.

**About Us**:
**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

**How to Apply**:
For further technical information relating to this position please refer to the Position Description or contact Ivan Siladji on (02) 9717 3484. For all other queries please contact Talent Acquisition on (02) 9717-9361.

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

**Application closing date: Thursday 18th April 2024 at 11.59pm**

**_All applicants must be Australian citizens._

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