Director, Quality Systems (Hybrid)

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

Position:

Director, Quality Systems provides strategic leadership and hands-on oversight for the design, implementation, maintenance, and continuous improvement of theQuality Management System (QMS). This role serves as a subject matter expert forGxPquality systems and is accountable for system governance, compliance, and operational excellence across electronic quality platforms.

The Director partners cross-functionally to ensure inspection-ready quality systems that meet global regulatory requirements, support clinical-stage development, and scale with organizational growth.

Responsibilities include:

Quality Systems Leadership

• Provide governance and oversight of theQuality Management System, ensuring sustained compliance with applicableGxPregulations.
• Monitor emerging and evolving global regulatory requirements and proactively drive updates to quality systems and procedures tomaintaina continuous state of compliance.

Electronic Quality Systems

• Lead the lifecycle management, configuration, and continuous improvement of electronic quality systems, including EDMS, LMS, and relatedGxPplatforms.
• Serve as system owner for Veeva Vault Quality, including user management, system configuration, document workflows, and reporting.

Computer System Validation & Assurance

• Lead and support validation activities forGxPcomputerized systems,demonstratingexpertisein Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Ensure allGxPsystemsremainin a validated state throughout their lifecycle, including change management and periodic review.
• Ensure compliance with 21 CFR Part 11 and applicable electronic records and signature requirements.

Document Control & Training

• Own and continuously improve the document control process, ensuring controlled documents are authored, reviewed, approved, distributed, and archived in compliance with internal procedures and regulatory expectations.
• Lead the administration and optimization of the learning management system, including training curricula, role-based training assignments, and compliance tracking.
• Partner with functional leaders to ensuretimelydocument review, approval, and training completion across the organization.

Metrics, Audits & Continuous Improvement

• Develop, monitor, analyze, and report quality system metrics to assess system health and support management review.
• Conduct periodic internal audits of quality systems and document control processes; ensuretimelyinvestigation and resolution of identified gaps or nonconformances.
• Identifyand drive continuous improvement initiatives to enhance efficiency, scalability, and compliance of quality systems.

Additional Quality Support

• Support inspections and audits, including regulatory authority and partner audits.
• Contribute to supplier quality, quality risk management, and broader QMS initiatives as needed.
• Performadditionalduties as assigned by management.

Education, Experience, and Skills:

Required:

• Bachelor’s degree ina relatedscientific or technical disciplinerequired.
• Minimum of ten (10) years of industry experience supportingGxPquality systems withinbiologics, pharmaceuticals, medical devices, or combination products.
• Strong working knowledge of electronic document management systems;Veeva Vault Quality experience highly preferred.
• Demonstratedexpertisein CSV, CSA, andGxPcomputerized system lifecycle management.
• In-depth understanding of FDA, ICH, and globalGxPregulations, including 21 CFR Part 11.
• Strong problem-solving, organizational, and communication skills.
• Ability to work independently while effectively collaborating in a cross-functional, fast-paced environment.
• High attention to detail with the agility to adapt to changing priorities.
• Continuous improvement mindset and comfortoperatingin a growing clinical-stage organization.

Comp $212-228K based on experience