Senior Associate, Quality Assurance Compliance x 2

We are recruiting two Senior Associate – Quality Assurance Compliance & Insights roles within our Quality Assurance Compliance team at our Broadmeadows site.

While both roles operate at the same level and within the same team, each role has a distinct primary focus:

• One role will focus on regulatory compliance, inspections, internal audits and quality systems

• The second role will focus on quality data, Power BI reporting, data visualization and continuous improvement

Both roles will work closely together and contribute to overall quality compliance, inspection readiness and performance reporting within a highly regulated pharmaceutical manufacturing environment.

Key responsibilities

Regulatory Compliance, Audits & Quality Systems

• Manage and maintain change notifications and quality agreements for intracompany, affiliates and external partners

• Co-ordinate readiness activities and participate in regulatory authority inspections, internal audits, mock inspections and customer audits

• Coordinate and maintain inspection readiness activities

• Manage CAPA development, tracking and closure in line with regulatory expectations

• Support the Self‑Inspection Program, including scheduling, execution, reporting and follow‑up

• Support Regulatory Standards Management, including impact assessments and implementation of new requirements

• Support the ongoing maintenance of the Quality Management System (QMS), including eQMS and training compliance

Quality Data, Reporting & Continuous Improvement

• Develop, maintain and enhance quality dashboards and reports, including Power BI visualizations

• Analyze and trend quality KPIs, metrics and performance indicators for site and global reporting

• Support Quality Management Reviews through data analysis and insight generation

• Drive improvements in data accuracy, extraction, reporting efficiency and standardization

• Support Annual Product Quality Reviews (APQRs) through data analysis, plausibility checks and trend evaluation

• Track and report actions arising from Quality Reviews and continuous improvement initiatives

About you

You are a motivated quality professional with strong analytical skills and a commitment to quality excellence.

You will bring:

• A bachelor’s degree in science, Engineering, Pharmaceutical Science or a related discipline

• Experience working in a pharmaceutical or GMP‑regulated environment

• Knowledge of GxP regulations, compliance and quality systems

• Strong analytical capability, with experience in data analysis and reporting (Power BI experience highly regarded)

• A continuous improvement mindset with strong problem‑solving skills

• Effective communication and stakeholder engagement skills

Note: While both positions will have exposure across these areas, the emphasis will differ depending on the role either regulatory compliance & audits or quality data & reporting.