Senior Quality Associate

The Senior Quality Associate is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with GMP requirements, regulatory obligations, customer expectations, and internal quality standards. Working closely with the Quality Manager and other departments, the role supports the management of quality systems, including deviations, CAPAs, change controls, customer complaints, supplier quality and validation activities, audits, training, and inspection readiness. The position also contributes to continuous improvement initiatives and helps to promote a proactive quality culture across the business. The Senior Quality Associate collaborates with internal teams, customers, suppliers, and regulatory authorities to support product quality, patient safety, and ongoing compliance. When required, the role may act as a delegate for the Quality Manager, supporting day-to-day quality activities and ensuring continuity of quality operations.

Responsibilities

Manage and continuously improve the Pharmaceutical Quality System (PQS), ensuring compliance with GMP, GXP, TGA, PIC/S, FDA, customer, and corporate requirements; Maintain and control quality documentation, including SOPs, specifications, forms, quality records, and change control processes; Lead investigations into deviations, non-conformances, complaints, and audit findings using risk-based decision-making and root cause analysis methodologies; Develop, implement, monitor, and verify the effectiveness of Corrective and Preventive Actions (CAPAs) to drive sustainable quality improvements; Monitor quality KPIs, trends, and metrics, providing insights and recommendations to support continuous improvement initiatives; Conduct and coordinate internal audits, self-inspections, supplier assessments, and audit remediation activities, ensuring actions are closed out effectively; Support customer audits and regulatory inspections, maintaining a high level of site inspection readiness at all times; Participate in quality risk assessments and support the implementation of risk-based approaches to reduce compliance and operational risks; Support supplier qualification and approval activities, including the review of supplier documentation, quality agreements, and ongoing performance; Review batch documentation and support batch disposition, product release activities, and management reporting where required.

Requirements

Bachelor's degree in Science, Pharmacy, Chemistry, Microbiology, Chemical Engineering, or a related discipline; At least 5 years' experience in Quality Assurance within a GMP-regulated pharmaceutical or therapeutic manufacturing environment; Strong knowledge of Pharmaceutical Quality Systems and regulatory requirements, including GMP, TGA, PIC/S and relevant industry standards; Hands-on experience managing quality systems, including deviations, CAPAs, change controls, investigations, complaints and document control; Experience supporting customer audits, regulatory inspections and internal audit programs; Sound understanding of root cause analysis, risk assessment and problem-solving methodologies; Proven ability to review and approve GMP documentation with a high level of accuracy and attention to detail; Strong communication and stakeholder management skills, with the ability to build effective relationships across all levels of the organisation; Excellent organisational skills and the ability to manage multiple priorities in a fast-paced manufacturing environment; A proactive, solutions-focused mindset with strong analytical skills, sound judgement and a commitment to continuous improvement.

Nice to have

Experience working within a Contract Manufacturing Organisation (CMO) environment; Knowledge of validation and qualification activities; Internal Auditor or Lead Auditor qualification; Experience analysing quality data and trends to support decision-making and continuous improvement initiatives.