Experienced QA Consultant for Robust Pharmaceutical Quality Systems

With over two decades of hands-on experience in pharmaceutical quality assurance, I specialize in helping companies build, refine, and maintain inspection-ready Quality Management Systems (QMS). My consultancy work spans a wide range of activities critical to regulatory compliance, including batch record review, change control management, CAPA systems, and documentation oversight—all tailored to EU GMP, GDP, ISO, and FDA expectations. I’ve worked with startups as well as global leaders like Pfizer, Janssen, Moderna, and Merck to bring quality systems up to standard—and beyond.

My strength lies in translating complex regulations into practical, efficient processes that integrate seamlessly into your organization. Whether you’re preparing for a product launch, scaling up operations, or responding to audit findings, I offer direct, actionable support. From reviewing executed batch records and validation documentation to mapping and improving deviation and change control processes, I bring clarity and structure to every stage of quality assurance.

Clients frequently rely on me to lead or recover QMS improvement projects following inspection findings. I’ve redesigned documentation systems, built training programs, improved product quality review processes, and implemented integrated deviation and CAPA frameworks that stand up to rigorous Health Authority scrutiny. My work has consistently contributed to successful GMP certifications, manufacturing authorizations, and inspection outcomes across Europe and beyond.

If you’re looking for a QA consultant who not only knows the regulations but can help implement them in a way that adds value—not bureaucracy—let’s connect.
Contact me today to discuss how I can support your quality operations, strengthen compliance, and reduce audit risk.