Jon Halling
Jon Halling is an independent pharmaceutical quality, compliance and manufacturing consultant with more than 30 years’ experience across biologics, vaccines and advanced therapies.
He works with biopharma leadership teams navigating regulatory complexity, manufacturing risk and high-stakes development milestones.
Connect on LinkedInTechnical & Regulatory Experience
Jon’s experience includes monoclonal antibodies, recombinant proteins, viral vectors, advanced therapy medicinal products, and live attenuated viral vaccines. He has supported programmes from early development through clinical manufacturing and regulatory submission readiness.
He has extensive interaction experience with global regulatory authorities including MHRA, FDA, PMDA, TGA and ANVISA. His expertise spans Quality Assurance leadership, validation and qualification of facilities and equipment, analytical and process interfaces, GMP training and compliance oversight.
How I Work
My approach is pragmatic, structured and outcome-focused. I work alongside leadership and cross-functional teams to clarify risk, align strategy and establish defensible quality and manufacturing decisions.
Typical Engagement
- Initial diagnostic review — independent assessment of programme status, regulatory positioning and manufacturing readiness.
- Risk prioritisation — identification of critical quality, compliance and CMC risks impacting delivery timelines.
- Strategic alignment — working with leadership and technical teams to define clear, defensible development pathways.
- Targeted implementation support — focused input across remediation, inspection readiness, tech transfer or development planning activities.