Senior GMP Manufacturing & AI Advisor

AustraliaRemoteContractsenior

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Quick Summary

Key Responsibilities

Analyze end-to-end autogenous vaccine development and manufacturing processes to identify operational bottlenecks, inefficiencies, and decision-making challenges.

Requirements Summary

The ideal candidate combines extensive hands-on pharmaceutical manufacturing experience with recent practical expertise in artificial intelligence and regulatory compliance.

Technical Tools

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As a Senior GMP Manufacturing & AI Advisor, you will leverage extensive pharmaceutical manufacturing expertise and advanced artificial intelligence knowledge to drive innovation within regulated production environments. You will assess complex manufacturing processes, identify operational bottlenecks, and develop AI-driven solutions that improve efficiency, quality, and decision-making. Working across manufacturing, quality, and technology functions, you will help organizations integrate AI into critical GxP-regulated processes while maintaining strict compliance standards. You will advise senior stakeholders on AI opportunities, regulatory readiness, and implementation strategies. This role combines strategic consulting with practical industry expertise, offering the opportunity to shape the future of intelligent pharmaceutical manufacturing through scalable, compliant innovation.

As a senior advisor, you will evaluate manufacturing operations, identify opportunities for AI adoption, and guide the implementation of innovative solutions within GMP-regulated environments. Your responsibilities will include:

Analyze end-to-end autogenous vaccine development and manufacturing processes to identify operational bottlenecks, inefficiencies, and decision-making challenges.
Assess opportunities to introduce AI-driven solutions, including predictive analytics, document automation, workflow optimization, and intelligent decision-support systems.
Develop, evaluate, and prioritize AI initiatives based on technical feasibility, business value, operational impact, and implementation potential.
Support the development of regulatory-compliant organizational frameworks aligned with current and emerging AI regulations.
Assess manufacturing sites to evaluate their technological maturity, operational readiness, and suitability for AI implementation.
Recommend appropriate pilot locations and identify opportunities for initial AI deployment.
Conduct stakeholder interviews and gather operational insights to understand business needs and transformation priorities.
Present strategic recommendations, implementation roadmaps, and AI adoption opportunities to senior leadership and executive stakeholders.
Contribute to the design and development of pilot programs for AI solutions within GMP-regulated manufacturing environments.
Define scalable AI deployment strategies that support long-term operational improvements while maintaining regulatory compliance.
Ensure AI initiatives align with pharmaceutical quality standards, data integrity requirements, and applicable validation frameworks.

Requirements

~2 min read

The ideal candidate combines extensive hands-on pharmaceutical manufacturing experience with recent practical expertise in artificial intelligence and regulatory compliance. You should bring:

At least 12 years of hands-on GMP manufacturing experience within the pharmaceutical, biotechnology, or animal health industries.
Proven operational experience in Production, Quality Assurance, Manufacturing Science and Technology (MS&T), or Engineering.
Strong practical knowledge of batch execution, deviation management, and regulatory inspections.
Demonstrated experience delivering AI or advanced analytics use cases within GMP-regulated environments during the last 24 months.
Expertise in Generative AI and AI agent solutions applied to GxP-regulated processes.
Strong understanding of AI and machine learning validation, data integrity, and pharmaceutical compliance requirements.
Knowledge of relevant regulatory and validation frameworks, including GAMP 5, Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
Experience conducting manufacturing site assessments and evaluating operational and technological maturity.
Proven ability to advise senior leadership teams on manufacturing transformation, AI adoption, and regulatory readiness.
Up-to-date knowledge of evolving AI regulations and GMP requirements within the pharmaceutical industry.
Excellent communication, consulting, and stakeholder management skills.
Ability to translate complex technical, operational, and regulatory topics into clear recommendations for executive audiences.
Fluent written and spoken English.
Strong analytical thinking, problem-solving abilities, and a strategic approach to digital transformation.