Quality & Training Associate

Planet Pharma; Melbourne; On-site; AUD 85,000 - 110,000; Full time

Job summary

Planet Pharma in Melbourne, Australia is seeking a Quality & Training Associate to strengthen quality systems, ensure regulatory compliance, and develop workforce capability across the organisation. You will partner with study teams and clients to keep activities inspection-ready and aligned with ICH-GCP and internal SOPs, supporting audits, CAPAs, and continuous improvement.

This role offers long-term career growth in clinical quality, training, and operations within a collaborative CRO

Qualifications

• Experience in CRO/clinical research environment.
• Hands-on quality and compliance activities experience.
• Exposure to QMS, SOPs, CAPAs, deviations, and audits.

Responsibilities

• Support ongoing management and improvement of the Quality Management System (QMS).
• Maintain quality documentation, including SOPs, work instructions, CAPAs, deviations, change controls, and training records.
• Assist with internal and external audits, sponsor assessments, and inspection readiness activities.
• Participate in investigations, root cause analyses, corrective actions, and continuous improvement initiatives.
• Ensure quality documentation remains accurate, current, and compliant.
• Engage in risk assessments and process improvement projects.
• Collaborate with operations to promote a strong quality culture.

Skills

ICH-GCP knowledge

Quality & compliance experience

QMS experience

SOPs & CAPAs management

Attention to detail

Stakeholder management

Independent working

Job description

About the Opportunity

We are partnering with a growing, specialist clinical research organisation that is entering an exciting phase of expansion and operational maturity.

As part of this growth, the business is seeking a Quality & Training Associate to play a key role in maintaining and strengthening quality systems, compliance standards, and workforce capability across the organisation.

This is an opportunity to join a highly collaborative environment where quality is viewed as a business enabler rather than an administrative function. The successful candidate will work closely with operational leaders, study teams, and clients to ensure clinical research activities remain inspection-ready, compliant, and aligned with industry best practice.

For someone looking to build a long-term career within clinical quality, compliance, and operations, this role offers genuine visibility, responsibility, and future growth potential.

The Role

You will act as a key resource across both Quality and Training, helping ensure clinical programs are delivered in accordance with ICH-GCP, sponsor expectations, and internal quality standards.

Responsibilities will include:

Quality & Compliance

• Support the ongoing management and improvement of the Quality Management System (QMS).
• Maintain quality documentation, including SOPs, work instructions, CAPAs, deviations, change controls, and training records.
• Support internal audits, external audits, sponsor assessments, and inspection readiness activities.
• Assist with investigations, root cause analyses, corrective actions, and continuous improvement initiatives.
• Ensure quality documentation remains accurate, current, and compliant.
• Participate in risk assessments and process improvement projects.
• Partner with operational teams to promote a strong quality culture across the organisation.

Training & Development

• Coordinate and maintain organisation-wide training and competency programs.
• Manage training records and compliance tracking.
• Support onboarding and induction activities.
• Coordinate GCP, SOP, systems, and process-related training.
• Ensure all training documentation remains audit-ready and inspection-ready.
• Support the development of learning resources and training materials.

Stakeholder Engagement

• Act as a trusted point of contact for quality and compliance queries.
• Work closely with cross-functional clinical research teams.
• Support client-facing quality activities as required.
• Build strong relationships across operational and leadership teams.

About You

You will likely bring:

• Experience working within a CRO, clinical research, or clinical trials environment.
• Strong understanding of ICH-GCP requirements.
• Hands-on experience supporting clinical quality and compliance activities.
• Exposure to Quality Management Systems (QMS).
• Experience managing SOPs, CAPAs, deviations, document control, or audit activities.
• Excellent organisation and attention to detail.
• Strong communication and stakeholder management skills.
• A proactive approach and the ability to work independently.

Why Consider This Opportunity?

• Join a growing and highly regarded clinical research organisation.
• Broad exposure across quality, compliance, training, and operations.
• Work directly with experienced industry leaders.
• Genuine opportunity to influence processes and contribute to organisational growth.
• Strong career development potential as the business continues to expand.
• Collaborative culture where individuals are encouraged to take ownership and make a visible impact.