Quality Manager

Sonic Clinical Trials; Sydney; On-site; AUD 120,000 - 170,000; Full time

Job summary

Sonic Clinical Trials in Macquarie Park, NSW, is seeking an experienced Quality Manager for a 6-month fixed-term contract to lead the Quality Management System and drive continuous improvement. You will collaborate across global operations to coordinate investigations, CAPAs, deviations and audits, ensuring ongoing compliance with ICH GCP, GCLP, ISO 15189/17025 and related standards.

Strong stakeholder engagement, cross‑functional teamwork and audit readiness are essential for success in this

Qualifications

• Experience in Quality Management within a regulated environment (clinical trials, pathology, healthcare or laboratory services).
• Proven experience leading investigations, deviations, complaints, CAPAs, change controls and risk assessments.
• Strong knowledge of quality management systems and regulatory/ accreditation requirements (ICH GCP, GCLP, ISO 15189, ISO 17025).

Responsibilities

• Support day-to-day operation and continuous improvement of the QMS.
• Coordinate and facilitate quality events, investigations, deviations, complaints and CAPAs.
• Provide quality and compliance support to laboratory, operational and support teams.
• Assist with planning, coordination and follow-up of internal, client, sponsor and regulatory audits and inspections.
• Review and approve quality documentation per control requirements.
• Support change control, risk assessment and quality improvement initiatives.
• Facilitate quality training and promote awareness of quality and compliance requirements.

Skills

Quality Management

Audits & Compliance

CAPA & Deviation

Root Cause Analysis

Risk Assessment

Document Control

Stakeholder Management

Investigation Leadership

Change Control

Regulatory Knowledge (ICH GCP/GCLP ISO

Education

Science or Biomedical Science degree

Job description

Sonic Clinical Trials – Macquarie Park NSW

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 (with possibility of extension).

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.