IT Systems & Validation Manager

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 one of Australia's fastest-growing pharmaceutical companies, and we're changing what's possible in emerging therapeutics. We were the first Australian company licensed to manufacture psilocybin and MDMA as active pharmaceutical ingredients. Our TGA GMP-licensed facilities manufacture Schedule 3, 4 and 8 medicines, and we supply patients and partners around the world.

We're growing fast, and our digital infrastructure needs to keep up. That's where you come in.

About BLS Pharmaceuticals

BLS Pharmaceuticals is one of Australia's fastest-growing pharmaceutical companies, and we're changing what's possible in emerging therapeutics. We were the first Australian company licensed to manufacture psilocybin and MDMA as active pharmaceutical ingredients. Our TGA GMP-licensed facilities manufacture Schedule 3, 4 and 8 medicines, and we supply patients and partners around the world.

We're growing fast, and our digital infrastructure needs to keep up. That's where you come in.

The opportunity

This is a rare chance to build a function from the ground up. As our IT Systems & Validation Manager, you'll take end-to-end responsibility for the IT landscape at BLS Pharmaceuticals. That covers the GMP systems our core operating departments depend on and the business systems that keep the company running.

You'll shape how BLS Pharmaceuticals selects, implements, validates and runs technology as it scales.

What you'll do

Computerised systems validation and GMP compliance

• Lead and deliver the company's computerised systems validation (CSV) programme, covering planning, URS, risk assessment, supplier assessment, test protocols, traceability and validation summary reports.

• Build and maintain the computerised system inventory and GMP impact assessments.

• Bring systems already in use into a validated, controlled state using a risk-based approach.

• Act as system owner for GMP computerised systems and manage their lifecycle controls: change and configuration management, periodic review, incident management, access reviews, audit trail review, backup and restore testing, business continuity and archiving.

• Write and maintain CSV and IT governance procedures that meet PIC/S Annex 11, data integrity expectations and GAMP 5.

• Support TGA and international regulatory inspections, customer audits and internal self-inspections as the subject-matter expert for computerised systems.

IT systems and operations (GMP and non-GMP)

• Manage the BLS Pharmaceuticals IT environment, including Microsoft 365, SharePoint, networks, end-user devices, security and access management.

• Act as system owner or administrator for key platforms, including ERP, eQMS, inventory management, and laboratory and facility systems.

• Lead cybersecurity, identity and access management, and IT risk management.

• Manage IT service providers, SaaS vendors and implementation partners, including contracts, SLAs and quality agreements.

Projects and growth

• Help choose and implement new systems as BLS Pharmaceuticals expands, making sure each one is compliant from the start.

• Work with Quality, Production, Supply Chain, Finance and senior leadership to turn business needs into practical technology solutions.

About you

• Proven, hands-on computerised systems validation experience in a GMP-regulated pharmaceutical, biotech or medical device environment.

• Sound working knowledge of PIC/S GMP Annex 11, GAMP 5 (Second Edition) and data integrity principles (ALCOA+).

• Experience validating configured and SaaS or cloud systems, such as ERP, eQMS, LIMS or inventory systems, using a risk-based approach.

• Broad IT operations experience: Microsoft 365 administration, networks, security, and user and access management.

• The ability to work autonomously: setting priorities, managing your own workload and delivering with minimal supervision.

• Clear, practical communication, including explaining technical and regulatory concepts to non-specialists.

• A tertiary qualification in IT, computer science, engineering, science or a related discipline.

What we offer

• A newly created role with real ownership and room to shape the function.

• Work at the frontier of Australian pharmaceutical manufacturing, including psychedelic-assisted therapies and emerging medicines.

• Direct exposure to senior leadership and international markets.

• A fast-paced, collaborative environment where your work makes a visible difference.

• A competitive salary package.

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