Senior GMP Manufacturing & AI Advisor

Accountabilities:

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:

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.

Benefits:

• Fully remote working arrangement, with worldwide location flexibility.

• Freelance / independent contractor engagement.

• Opportunity to work on innovative AI transformation initiatives within the pharmaceutical and biotechnology sectors.

• Exposure to advanced AI applications in highly regulated GMP manufacturing environments.

• Strategic advisory responsibilities with direct interaction with senior leadership and key stakeholders.

• Opportunity to influence the development of scalable, compliant AI solutions and manufacturing processes.

• Engagement with complex manufacturing operations, including autogenous vaccine development.

• Opportunity to contribute to the modernization of pharmaceutical manufacturing through artificial intelligence and advanced analytics.

• Start date: As soon as possible.