Senior Quality Associate, China (City of Sydney)

If you are looking for a fantastic team and a challenging, rapid, and dynamic work environment, you are at the right place! On our journey to making a positive difference across the world, you will work with passionate people in an innovative and collaborative organization as we inspire wellness through purpose‑led careers. We are dedicated to our customers, community, and environment and are looking for similar‑minded talent to join us! As an equal opportunity employer, we care deeply about creating an inclusive workplace where our team members feel valued, respected, and empowered. Our total rewards package includes additional annual leave, bonuses, wellness programs, health benefits, flexible and remote working arrangements, and performance awards — not to mention various social and recreational activities, all of which are regionally specific. With over 3,400 team members working across the globe, our vision is focused on premium nutrition and lifetime wellness, backed by science. We have three business segments – Baby, Adult and Pet Nutrition and Care – supporting whole‑family health and happiness across seven international brands. What this means for you The variety of work creates unlimited opportunities to excel across a breadth of disciplines; you will be presented with a wealth of new pathways and opportunities to explore throughout your career. Working with us will be more than just a job; we guarantee a life‑changing experience as you step into an environment that moves quickly and presents new challenges daily. Your role within the team Reporting to the Quality Manager, the Senior Quality Associate plays a key role in ensuring excellence across Quality Operations within a regulated manufacturing environment. This position is responsible for end‑to‑end quality oversight of New Product Development (NPD) and Existing Product Development (EPD), including specifications, risk assessments, trials, stability, and batch release. You will lead investigations into deviations and OOS/OOT events, support commercial production activities, and work closely with contract manufacturers to manage quality requirements and daily operations. The role also involves overseeing change controls, supporting stability programs, and ensuring timely, compliant product release to market. In addition, you will contribute to maintaining compliance with GMP standards and support broader Quality System activities. We seek a proactive, solutions‑focused professional who demonstrates strong attention to detail, a commitment to continuous improvement, and a right‑first‑time mindset in delivering high‑quality outcomes. This role will be based in Sydney. Key responsibilities include
- Ensure quality oversight of NPD and EPD projects, including review and approval of specifications, CM briefs, and risk assessments
- Provide quality guidance on pre‑commercial and ongoing stability programs
- Conduct physical sample reviews and support first batch release to ensure compliance with specifications and regulatory requirements
- Manage ongoing stability programs, including coordination with local and international contract manufacturers and raising purchase orders
- Initiate and manage Change Controls, and approve quality‑related actions within the Change Control system
- Liaise with external laboratories for new testing capabilities and manage ongoing relationships and accounts
- Collaborate with contract manufacturers and suppliers, including leading regular quality meetings (“Quality Connects”)
- Coordinate external contract testing (chemical and microbiological), including sample management and review of results
- Prepare, analyse, and report quality metrics for Management Review, escalating significant quality or compliance risks (e.g., OOS/OOT)
- Maintain compliant documentation (SOPs/WIs), support supplier qualification, and deliver training and induction for new employees Desired Skills & Experience
- Tertiary qualification in Science/Engineering or 5+ years’ experience in pharmaceutical or TGA regulated industries.
- Strong knowledge of regulatory requirements, including Quality Systems, Compliance, and Risk Management.
- Experience in pharmaceutical or complementary medicines manufacturing environments.
- Solid understanding of laboratory operations and quality practices.
- Proficiency in Microsoft Office (Word, Excel) and Quality Management Systems (QMS).
- Skilled in investigating deviations and OOS results using root cause analysis and implementing CAPAs.
- Experience with Document Control and Change Control processes.
- Excellent communication, organisational, and time‑management skills.
- Proven ability in problem solving, critical analysis, and decision making.
- Experience in training staff, Product Quality Reviews, complaints management, and stability program oversight.
- Mandarin language is desirable but not essential.
- Capacity to travel at short notice to manufacturing sites, suppliers, or other business locations, as required to support quality activities.
- Based in Sydney. H&H; Group believes in the benefits of a diverse & inclusive workplace & aims to reflect the varied cultures within which we exist. We are committed to providing a working environment that is free from discrimination & harassment, creating a safe and inclusive environment for all. We encourage applications from people of all ages, nationalities, religions, racial and gender identities, sexual orientations, abilities and cultures, & our hiring decisions will be based on business needs, position requirements, & the qualifications and experience of individuals. If you require support or assistance during the application process, please notify us at the time of application and we will be sure to enable reasonable adjustments where suitable. #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rwe5x