Quality Assurance Manager/Senior Quality Assurance Manager - Remote

About Us Southern Star Research is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance. Southern Star Research has been recognized for its outstanding contributions to the field, winning prestigious awards such as the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award and being named as Great Place to Work in Australia in 2024 and 2025. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage. The role We are looking for an experienced Quality Assurance Manager or Senior Manager to join our growing team. As a QA Manager/Senior Manager at Southern Star, you’ll work in an exciting and fast-paced environment, assisting the Head of Quality Assurance in the execution of a broad range of quality activities and help to embed a quality culture within the organisation. This role is flexible on location and can be based across Australia, Singapore, Malaysia or the Philippines. Reporting to the Head of Quality Assurance, you’ll be responsible for:

• Management of client audits
• Management of GXP audits for vendors
• Assist with quality assurance queries from internal teams, ensuring QMS and GCP compliance
• Review and development of quality management documentation
• Support the preparation and management of regulatory inspections
• Work as a backup to the head of quality assurance
• Management of strategic QA initiatives to support company growth, such as expanding use of Veeva for audits, deviations, CAPA’s and risk management

To be successful in the role, we’re looking for candidates with:

• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.
• A minimum of 4 years' quality assurance experience within a CRO or pharmaceutical company, including client and vendor audit experience
• Experience with Veeva is preferred
• Excellent planning and organisational skills, with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• A sound knowledge and understanding of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations;
• Exceptional communication skills as well as strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity;
• Demonstrated business ethics and integrity;

Why Southern Star?

• Join a passionate team committed to our shared purpose to create brighter futures, one study at a time.
• Exciting growth phase, creating ongoing career development opportunities for our teams
• Competitive remuneration
• Flexible work environment, with hybrid and fully remote options
• STAR day - an extra day off per year for you to recharge.

Diversity, Equity and Inclusion At Southern Star Research, we are committed to fostering a safe, inclusive, and respectful workplace where everyone feels valued and empowered to contribute. We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences. We are dedicated to ensuring an inclusive recruitment process and providing equal opportunities for all applicants, regardless of race, ethnicity, gender identity, sexual orientation, age, disability, or cultural background.