Quality Manager - 6 month fixed term

Sonic Clinical Trials; Sydney; On-site; AUD 150,000 - 230,000; Full time

Job summary

Sonic Clinical Trials (SCT) is seeking an experienced Quality Manager to lead quality systems, investigations, CAPAs and audits across SCT's global operations from our Macquarie Park head office.

You will collaborate with laboratory, operational and support teams to drive continuous improvement, ensure ongoing regulatory compliance and maintain audit readiness across multiple regions and time zones.

Qualifications

• Tertiary qualification in Science, Biomedical Science or a related discipline.
• Demonstrated experience in a Quality Management role within a regulated environment, preferably clinical trials, pathology, healthcare or laboratory services.

Responsibilities

• Support the day-to-day operation and continuous improvement of SCT's Quality Management System (QMS).
• Coordinate and facilitate quality events, investigations, deviations, complaints and CAPAs, ensuring timely completion and follow-up.
• Provide quality and compliance support to laboratory, operational and support teams.
• Assist with the planning, coordination and follow-up of internal, client, sponsor and regulatory audits and inspections.
• Review and approve quality documentation in accordance with document control requirements and delegated authority.
• Support change control, risk assessment and quality improvement initiatives.
• Facilitate quality training and promote awareness of quality and compliance requirements across the organisation.

Skills

Quality management

Stakeholder management

Analytical skills

Problem solving

Audit readiness

Change control

Education

Science/Biomedical Science degree

Job description

Sonic Clinical Trials (SCT) is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology & medical device clinical trials, and a wholly owned subsidiary of Australian-owned Sonic Healthcare, one of the world's largest specialist medical diagnostics companies.

As we continue to grow and explore global opportunities, we have an outstanding opportunity for an experienced Quality Manager to join the team on a 6 month fixed term contract.

The role supports quality and compliance activities across SCT's global operations, partnering with laboratory, operational and support teams to maintain effective quality systems, ensure ongoing compliance, and foster a culture of continuous improvement and audit readiness. The successful candidate will work collaboratively across multiple regions and functions, supporting investigations, CAPAs, audits and quality system activities. The role requires flexibility, strong stakeholder engagement skills, and the ability to work effectively with diverse teams across different cultures and time zones.

The position is based within a dynamic team environment at our Macquarie Park Head Office.

Key Responsibilities

• Support the day-to-day operation and continuous improvement of SCT's Quality Management System (QMS).
• Coordinate and facilitate quality events, investigations, deviations, complaints and CAPAs, ensuring timely completion and follow-up.
• Provide quality and compliance support to laboratory, operational and support teams.
• Assist with the planning, coordination and follow-up of internal, client, sponsor and regulatory audits and inspections.
• Review and approve quality documentation in accordance with document control requirements and delegated authority.
• Support change control, risk assessment and quality improvement initiatives.
• Facilitate quality training and promote awareness of quality and compliance requirements across the organisation.

About You

• Tertiary qualification in Science, Biomedical Science or a related discipline.
• Demonstrated experience in a Quality Management role within a regulated environment, preferably within clinical trials, pathology, healthcare or laboratory services, minimum 10 -15 years.
• Strong working knowledge of quality management systems and applicable regulatory and accreditation requirements, including ICH GCP, GCLP, ISO 15189, ISO 17025 or equivalent frameworks.
• Proven experience leading complex investigations, deviations, complaints, CAPAs, change controls and risk assessments.
• Experience supporting internal, client, sponsor, accreditation and regulatory audits and inspections.
• Strong analytical and problem-solving skills, with the ability to assess quality risks, identify root causes and drive timely resolution of quality issues.
• Strong stakeholder management skills, with the ability to work effectively across laboratory, operational and support functions.
• Ability to influence positive quality behaviours and build strong working relationships in a collaborative and solutions-focused manner.
• Highly organised, adaptable and capable of managing multiple priorities in a fast-paced and highly regulated environment.
• A commitment to quality, compliance, continuous improvement and maintaining ongoing audit and inspection readiness.

Background checks, including a National Police Check, will be required prior to commencement.