Senior Quality Associate, China

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

With 3,400+ team members globally, we focus on premium, science ‑ backed nutrition across Baby, Adult, and Pet categories, spanning seven international brands.

We’re a passionate, collaborative team working in a fast ‑ paced and dynamic environment, inspired by#PurposeLedCareers and focused on making a positive impact worldwide.

We’re committed to our customers, community, and environment, and to creating an inclusive workplace where everyone feels valued and empowered. Our total rewards include additional leave, bonuses, wellness and health benefits, hybrid working, a s well as social activities .

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 ensures all aspects of Quality Operations are carried out. You will manage the end-to-end quality aspects of NPD and EPD projects, from CM briefs, product specifications, risk assessments, stability evaluation and timely, compliant first commercial batch release. You will lead deviation and OOS/OOT investigations, approve product specifications, liaise with contract manufacturers, support the stability program, manage change controls, and attend commercial production when required. You will also support the Quality System Team with PIC/S GMP compliance, foster Continuous Improvement and Right First Time, and proactively address risks with a can-do attitude.

Key responsibilities include:

• Sign off product specification for new and existing products
• Manage change controls
• Manage ongoing stability, including signing off stability protocols, raising POs, with local and international contract manufacturers.
• Liaise with contract manufacturers regarding non-conformances and customer complaints
• Liaise with cross functional teams during new product development
• Arrange external contract testing (e.g. chemical and micro testing) with approved laboratories, set up new areas of testing, and manage accounts, samples and results.
• Liaise with strategic suppliers and CMs (including occasional visits, as required), and manage scheduled ‘Quality Connects’.
• Prepare and review metrics for the Management Review.
• Notify the Quality Manager of significant quality challenges that may affect product quality or regulatory compliance (e.g. OOS, OOT), and of key Quality and Compliance metrics.
• Participate in document control (SOPs / WIs), and new employee induction and ongoing training where required.
• Participate in supplier qualification, including review of GMP/Quality Agreements.
• Demonstrate the Swisse pledge for benchmark standards, and participate in Good Documentation Practice (GDP) and Good Housekeeping Practice (GHP).

Desired Skills & Experience

We look for people who have what it takes to make an impact; who can challenge us to go further while pushing themselves to deliver exciting & ambitious results.

To make sure we’re setting new starters up for success, we ask that you meet a few criteria relevant to the role to be considered for this opportunity:

• Experience in pharmaceutical or complementary medicines manufacturing.
• Investigating deviations and OOSs using root cause analysis tools and implementing corrective and preventative actions.
• Experience with document control, change control, product quality reviews, complaints management, stability program management, and training and induction of new employees.
• A relevant tertiary qualification in science or engineering, or at least 5 years’ experience in a similar pharmaceutical or regulated medical industry.
• Understanding of regulatory requirements for therapeutic and non-therapeutic products, including working knowledge of quality systems, risk management and compliance, plus knowledge of laboratory operations.
• Proficiency in Microsoft Office (Word and Excel) and quality management systems.
• Excellent written, verbal, presentation, organisational and follow-up skills.
• Strong problem-solving, team-building, planning, decision-making and time management skills, with the ability to analyse and critically assess information and provide guidance and advice based on your experience.
• Mandarin is desirable but not mandatory.

This role is based in Sydney (hybrid)

Ability to travel at short notice (mainly within Sydney and occasionally interstate)

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.

If you have what it takes, please apply via the online portal & we will be in touch soon. We move quickly & may fill the role prior to the application close date, so we suggest you get in touch today!