Senior Quality Associate

Role overview

The Senior Quality Associate plays a key part in supporting quality work across the full lifecycle of new product development and existing products at JSHealth Vitamins. Partnering with the Quality Manager, Regulatory Affairs, NPD, and Operations teams, this role helps ensure products are created, reviewed, and maintained in line with GMP standards, TGA obligations, and the company’s internal quality framework.

This is a practical, varied quality position for someone with strong attention to detail, confidence in a regulated setting, and a real interest in product compliance and quality outcomes.

NPD and EPD quality support

• Contribute quality expertise throughout the stage-gate development process, from early concept work through launch and ongoing lifecycle activities.
• Assess and sign off product specifications, packaging materials, and artwork to confirm they meet quality and regulatory expectations.
• Help prepare and keep up-to-date the quality records and documentation needed for both new launches and existing products.

Change control and quality programs

• Support the product change control process by reviewing, documenting, and helping implement changes in line with quality procedures.
• Assist with CAPA activities, including investigation support, tracking corrective actions, and checking whether actions have been effective.
• Participate in allergen assessments and raw material reviews linked to product changes and NPD workflows.
• Make sure quality activities remain aligned with relevant Australian requirements, including TGA and ARTG obligations, as well as applicable international market standards.

Pharmacovigilance and product complaints

• Help monitor and triage adverse events, documenting them in accordance with TGA pharmacovigilance requirements and internal SOPs.
• Maintain pharmacovigilance records, including MedDRA-coded adverse event logs and safety reporting timeframes.
• Support periodic safety report preparation and help keep PV processes inspection-ready.
• Assist in spotting potential product safety signals and escalate concerns to the relevant team lead when needed.
• Own the product quality complaint workflow end to end, including receiving, logging, triaging, and investigating complaints under GMP and QMS requirements.
• Work with manufacturers, suppliers, and internal stakeholders to resolve complaint investigations within agreed deadlines.
• Keep complaint records accurate and complete, and contribute to trend reviews to identify recurring issues or broader quality risks.
• Escalate complaints that meet reportable thresholds to the TGA or other relevant regulators when required.

Quality reviews and continuous improvement

• Contribute to product quality reviews, including annual reviews and ongoing monitoring of quality indicators.
• Proactively identify quality trends, risks, and issues, and help foster a continuous improvement mindset.
• Support the upkeep of the quality management system, including SOP review cycles and document control activities.

Cross-functional collaboration

• Work closely with Regulatory Affairs, NPD, Operations, and external suppliers to embed quality expectations into day-to-day work.
• Communicate clearly and promptly across teams, providing dependable quality input to project milestones and product decisions.

What the role calls for

To be successful in this role, you’ll bring a scientific background, experience in quality assurance within a regulated environment, and confidence working across product development, quality systems, and complaint handling. A solid grasp of GMP, TGA requirements, and quality management systems is important, along with the ability to work across multiple priorities in a fast-paced environment.

Qualifications and experience

• A bachelor’s degree in pharmacy, food science, chemistry, biochemistry, or a closely related scientific field.
• At least 5 years’ experience in a quality assurance role within a regulated environment, ideally in TGA-regulated, food, or pharmaceutical settings.
• Proven experience checking product specifications, packaging, and artwork against regulatory and quality standards.
• Practical understanding of GMP principles, TGA requirements, and quality management systems.
• Exposure to pharmacovigilance processes and adverse event reporting is preferred.

Skills and attributes

• Exceptional attention to detail and a strong commitment to accuracy.
• Well-developed organisational skills with the ability to balance several deadlines and priorities.
• Professional written communication skills and confidence producing high-quality documentation.
• A collaborative working style and the ability to build effective relationships across functions.
• Project coordination capability, with the discipline to track tasks through to completion.
• A proactive, solutions-oriented approach with the confidence to raise issues early.

Additional information

This position is based in Sydney, New South Wales, Australia and is a full-time, onsite role.

No salary or stipend has been specified for this position.

No vacancy count, start date, or application deadline has been provided.

If you are a detail-focused quality professional who wants to help shape products for a fast-growing wellness brand, this role offers the chance to contribute across quality, compliance, and product development activities.