Director, Quality Systems & GxP Compliance (CSV)

Planet Pharma; Brisbane (CA); On-site; USD 212,000 - 228,000; Full time

Job summary

Planet Pharma is seeking a Director, Quality Systems to provide strategic leadership for the QMS, ensuring compliance with global GxP requirements and readiness for inspections across electronic platforms. This role partners across functions to drive governance, validation, training, and continuous improvement, supporting clinical-stage development and scalable growth.

The ideal candidate has a ten-year background in GxP quality systems, experience with Veeva Vault Quality, and a track record of

Qualifications

• Bachelor’s degree in a related scientific or technical discipline.
• Minimum of ten (10) years of industry experience supporting GxP quality systems.
• Strong working knowledge of FDA, ICH, and global GxP regulations, including 21 CFR Part 11.
• Experience with EDMS/LMS and related GxP platforms.
• Demonstrated expertise in CSV, CSA, and GxP system lifecycle management.

Responsibilities

• Provide governance and oversight of the Quality Management System, ensuring sustained compliance with applicable GxP regulations.
• Lead lifecycle management, configuration, and continuous improvement of electronic quality systems (EDMS, LMS, Veeva Vault Quality).
• Lead validation activities for GxP computerized systems (CSV/CSA) and ensure systems remain validated throughout their lifecycle.
• Own document control processes and manage learning management system administration and training compliance.
• Develop and report quality system metrics; conduct internal audits and drive corrective actions.
• Support inspections and audits, including regulatory authority and partner audits; contribute to supplier quality and risk management.

Skills

GxP Quality Systems

CSV/CSA

Veeva Vault Quality

Regulatory compliance

Quality governance

Cross-functional leadership

Education

Bachelor’s degree in a related scientific or technical discipline

Tools

Veeva Vault Quality

Job description

Planet Pharma is seeking a Director, Quality Systems to provide strategic leadership for the QMS, ensuring compliance with global GxP requirements and readiness for inspections across electronic platforms. This role partners across functions to drive governance, validation, training, and continuous improvement, supporting clinical-stage development and scalable growth.

The ideal candidate has a ten-year background in GxP quality systems, experience with Veeva Vault Quality, and a track record of