Clinical Quality Director

i-Pharm Consulting; Sydney; On-site; AUD 140,000 - 200,000; Full time

Job summary

i-Pharm Consulting is seeking a Clinical Quality Manager to lead QA strategy and compliance for clinical development in Australia. Senior Manager / Associate Director level considered based on experience.

Responsibilities include QA oversight across SOPs, WIs, GxP guidance, risk and vendor management, and on-site audits to ensure alignment with global standards and regulatory requirements.

Qualifications

• Bachelor’s degree or higher in a scientific or healthcare discipline.
• 5+ years of experience in clinical research or clinical operations within biotech/pharma and/or CRO environments.
• 5+ years of experience in Quality Assurance / Quality Compliance.
• Strong understanding of QA methodologies and compliance in clinical development.
• GCP requirements for clinical trials.
• Regulatory authority inspection experience (preferred).
• Strong written and verbal communication skills.
• Full working rights in Australia.

Responsibilities

• Lead and execute overall Quality Assurance strategy supporting clinical development in the Australian office.
• Partner with Clinical Operations and cross-functional stakeholders to deliver QA oversight, including reviews of SOPs, WIs, and other quality management docs.
• Provide SOP clarification and GxP guidance (GCP and GMP) to support clinical development locally.
• Develop and implement risk management strategies for clinical operations.
• Develop and implement vendor management strategies, including audits and oversight.
• Lead and conduct on-site study site audits and create audit tools, checklists, and audit plans.
• Author and review audit reports and documentation; escalate quality/compliance issues as needed.
• Monitor emerging regulatory requirements and embed changes into policies and processes to maintain compliance.

Skills

QA methodologies

GCP guidance

Regulatory knowledge

Communication skills

Quality Assurance

Australia work rights

Education

Bachelor’s or higher in scientific/healthcare

Job description

We strive to create a collaborative, energized work environment focused on growth and opportunity. We value diversity, innovation, and a strong commitment to excellence and to the patients we serve.

About the Role

We are seeking a Clinical Quality Manager to head up and execute quality assurance strategy and compliance activities to support clinical development activities in Australia. This position is open to Senior Manager / Associate Director levels depending on the candidate’s depth of knowledge, skills, and relevant experience.

Responsibilities

• Lead and execute overall Quality Assurance strategy supporting clinical development in the Australian office.
• Partner with Clinical Operations and cross-functional stakeholders to deliver QA oversight, including:
• Review, comment on, and support revisions of SOPs, Work Instructions (WIs), and other quality management documentation with global stakeholders.
• Provide SOP clarification and GxP guidance (including GCP and GMP) to support clinical development locally.
• Develop and implement risk management strategies for clinical operations
• Develop and implement vendor management strategies, including:
• Lead and conduct on-site study site audits, including:
• Development/maintenance of audit tools, checklists, and audit plans
• Authoring and/or reviewing audit reports and audit documentation
• Timely escalation/communication of quality or compliance issues (critical findings, potential misconduct, significant deviations)
• Proactively monitor emerging regulatory requirements, guidance, and industry standards and ensure changes are communicated and embedded into policies, procedures, and business processes to maintain compliance.

Qualifications

• Bachelor’s degree or higher in a scientific or healthcare discipline (preferred).
• 5+ years progressive experience in clinical research or clinical operations within biotech/pharma and/or CRO environments.
• 5+ years experience in Quality Assurance / Quality Compliance.
• Strong understanding of QA methodologies and compliance approaches in clinical development.
• GCP requirements for clinical trials
• Regulatory authority inspection experience (preferred).
• Strong written and verbal communication skills.
• Full working rights in Australia required.

Required Skills

• Strong understanding of QA methodologies and compliance approaches in clinical development.
• Demonstrated knowledge and practical application of TGA regulations, ICH guidelines, and GCP requirements for clinical trials.
• Strong written and verbal communication skills.