IT Systems & Validation Lead — GMP/CSV Expert

Breathe Life Sciences PTY; City of Brisbane; On-site; AUD 140,000 - 200,000; Full time

Job summary

BLS Pharmaceuticals is rapidly expanding its IT function to govern GMP systems and business platforms. As IT Systems & Validation Manager, you will own validation across core GMP systems and business apps, shaping how technology is selected, implemented and run at scale.

You will lead CSV programmes, manage lifecycle controls, support regulatory inspections, and collaborate with Quality, Production, Supply Chain and Finance to deliver compliant, scalable tech solutions.

Qualifications

• Proven, hands-on CSV experience in GMP environments.
• Strong understanding of PIC/S Annex 11 and data integrity (ALCOA+).
• Experience validating SaaS/cloud systems like ERP/eQMS/LIMS.
• Ability to lead validation projects and manage regulatory inspections.

Responsibilities

• Lead CSV programme from planning through validation summaries.
• Maintain GMP impact assessments and system inventory.
• Validate systems using risk-based approaches and lifecycle controls.
• Serve as system owner for GMP computerised systems and manage changes.
• Write CSV and IT governance procedures meeting PIC/S Annex 11 and GAMP 5.
• Support TGA/regulatory inspections and internal audits.

Skills

CSV experience

GMP compliance

PIC/S Annex 11

GAMP 5

Data integrity

IT operations

Cybersecurity

Regulatory inspections

Stakeholder communication

Cloud/SaaS systems

Education

Bachelor's degree in IT, computer science, engineering or related field

Tools

ERP systems

eQMS

LIMS

Inventory systems

SharePoint / M365

Job description

BLS Pharmaceuticals is rapidly expanding its IT function to govern GMP systems and business platforms. As IT Systems & Validation Manager, you will own validation across core GMP systems and business apps, shaping how technology is selected, implemented and run at scale.

You will lead CSV programmes, manage lifecycle controls, support regulatory inspections, and collaborate with Quality, Production, Supply Chain and Finance to deliver compliant, scalable tech solutions.