Senior Quality Lead - Hybrid (GMP, NPD/EPD)

Swisse Wellness Pty; Sydney; Hybrid; AUD 100,000 - 130,000; Full time

Benefits offered by this job

Additional leave

Bonus

Wellness benefits

Hybrid working

Social activities

Job summary

Swisse Wellness Pty in Sydney seeks a Senior Quality Associate to manage end-to-end quality operations for NPD and EPD projects. You will lead deviations, OOS/OOT investigations, and ensure compliant batch releases, liaising with contract manufacturers, supporting stability, change controls and regulatory compliance.

The role requires a science/engineering qualification (or 5+ years in a regulated industry), strong analytical and communication skills, and hybrid work in Sydney.

Qualifications

• Experience in pharmaceutical or complementary medicines manufacturing.
• Investigating deviations and OOS using root cause analysis tools and implementing corrective actions.
• Experience with document control, change control, product quality reviews, complaints management, stability program management, and training/new employee induction.
• Knowledge of regulatory requirements for therapeutic and non-therapeutic products and GMP.
• Proficiency with quality management systems and risk management concepts.

Responsibilities

• Sign off product specifications for new and existing products.
• Manage change controls and ensure timely execution of actions.
• Oversee ongoing stability programs and sign off stability protocols and related POs.
• Liaise with contract manufacturers on non-conformances and customer complaints.
• Collaborate with cross-functional teams during new product development.
• Coordinate external testing with labs and manage samples and results.
• Plan and conduct Quality Connects with suppliers and CMs.
• Prepare and review Management Review metrics and quality KPIs.
• Escalate significant quality challenges affecting product quality or compliance.
• Contribute to document control, SOPs/WIs, and staff training.
• Participate in supplier qualification and GMP/Quality Agreement reviews.

Skills

Pharmaceutical manufacturing

Root cause analysis

Deviation investigations

Document control

Change control

Stability program

Quality systems

GMP compliance

MS Office

Training & induction

Education

Relevant tertiary qualification in science or engineering

Tools

Microsoft Office

Job description

Swisse Wellness Pty in Sydney seeks a Senior Quality Associate to manage end-to-end quality operations for NPD and EPD projects. You will lead deviations, OOS/OOT investigations, and ensure compliant batch releases, liaising with contract manufacturers, supporting stability, change controls and regulatory compliance.

The role requires a science/engineering qualification (or 5+ years in a regulated industry), strong analytical and communication skills, and hybrid work in Sydney.