Clinical research
10 GCP quality assurance experts
These ten professionals have led GCP quality assurance for clinical trials in their own roles at pharmaceutical and biotech companies. A reader can learn how drug developers run GCP audits and prepare for regulatory inspections.
Professionals to explore
01—10Christopher Belschner
LinkedInExperience: Senior Manager, GCP Quality Assurance · Nuvalent, Inc.
Senior Manager, GCP Quality Assurance at Nuvalent, Inc., a biotechnology company, since 2025. Former Senior Manager, R&D QA (2024–2025) and Manager, Clinical QA (2022–2024) at Aurinia Pharmaceuticals Inc., and Manager, GCP Quality at Imara Inc. (2021–2022).
Eva Ruth
LinkedInExperience: Senior Director of GCP GVP GLP QA · Mirum Pharmaceuticals, Inc.
Senior Director of GCP GVP GLP QA at Mirum Pharmaceuticals, Inc. since 2023 and former Director of GCP GVP GLP QA there (2021–2023). The profile headline reads Head of GCP/GVP/GLP QA at Mirum Pharmaceuticals, and the current role entry says this person leads the team supporting clinical programs and builds quality processes and systems. Former Associate Director QA at Corcept Therapeutics (2018–2021).
George Tkhinvaleli, Ph.D.
LinkedInExperience: Senior Director, Head of GCP Quality Assurance · Aeglea BioTherapeutics
Former Senior Director, Head of GCP Quality Assurance (2019–2021) and Director Clinical Quality Assurance (2016–2019) at Aeglea BioTherapeutics, and Senior Director, Clinical Quality Assurance at Deciphera Pharmaceuticals (2021–2023). The profile describes clinical trial QA oversight, audit program management and inspection readiness, and its current entry is Senior Director Quality Assurance at Harpoon Therapeutics.
Harish Vallamparambil, MRQA
LinkedInExperience: Senior Manager - GCP Quality Assurance · InflaRx
Senior Manager - GCP Quality Assurance at InflaRx since 2023. Former Head of Audit Program (2019–2023) and Compliance Manager & GCP Auditor (2015–2019) at Emerald Clinical; the profile describes this person as a quality assurance auditor with expertise in GCP, GCLP, GDP and CSV audits.
Ilse Nelissen
LinkedInExperience: Head of Global Quality Auditing GCP and GLP · UCB
Head of Global Quality Auditing GCP and GLP at UCB since 2025. The profile describes more than 25 years in GCP quality, compliance, training and clinical operations and says this person led a team of auditors based in Belgium and China; it also lists Asia-Pac Strategy Lead, Global Quality - Clinical Trials & Safety at Bristol Myers Squibb (2018–2022).
Justin Tama
LinkedInExperience: Sr. Manager, GCP Quality Assurance · Madrigal Pharmaceuticals
Sr. Manager, GCP Quality Assurance at Madrigal Pharmaceuticals since 2023, where the profile says the role ensures clinical trial activities comply with GCP, GLP, ICH, FDA, EMA, MHRA and other country regulations and guidelines. Former Clinical QA Specialist II at BioCryst Pharmaceuticals, Inc. (2021–2023) and Quality Assurance Auditor at Syneos Health (2019).
Karin Kaiser
LinkedInExperience: Director QA-GCP · Tubulis GmbH
Former Director QA-GCP at Tubulis GmbH (2024–2026), where the profile says this person led the GCP quality strategy, including setting up the annual GCP audit program, and oversaw audits of GCP relevant vendors, clinical trial sites and self-inspections. The profile also lists GCP Audit Strategy Lead, Associate Director at Galapagos (2022–2024) and Associate Director QA GCP Tubulis ADC Innovation Center at Gilead Sciences since 2026.
Nancy Bitters
LinkedInExperience: Director Of GCP Operational Quality, Reg Intel and Inspection Readiness · Vertex Pharmaceuticals
Former Director Of GCP Operational Quality, Reg Intel and Inspection Readiness at Vertex Pharmaceuticals (2021–2025) and Director Of QA - GCP at Acceleron Pharma (2021). The profile also lists Sr GCP GVP Inspection Management Lead at EMD Serono, Inc. (2017–2021) and GCP Inspection Management Lead at Pfizer (2010–2017), and its current entry is Senior Director Quality Assurance at Neurvati Neurosciences.
Ruth Kromkamp
LinkedInExperience: Director, GCP GLP R&D Quality Assurance · Kyowa Kirin International plc.
Director, GCP GLP R&D Quality Assurance at Kyowa Kirin International plc. since 2024 and former Associate Director GCP GLP QA there (2022–2024). The profile also lists Manager Regulatory Compliance at Gilead Sciences (2020–2022) and Senior Quality Assurance Manager at Astellas Pharma Europe (2015).
Theresa Sheehan
LinkedInExperience: Director, GCP - Quality · Venatorx Pharmaceuticals, Inc.
Former Director, GCP - Quality at Venatorx Pharmaceuticals, Inc. (2019–2022) and Director, R&D Quality Assurance at Acadia Pharmaceuticals (2017–2019), and Senior Director, Quality Assurance and Compliance at Uniquity Bio since 2022. The profile describes a GCP and pharmacovigilance QA and compliance background spanning domestic and international clinical investigator, pre-agency inspection and process audits.
Choose the right perspective
Match the person's setting to yours, since building GCP quality from scratch at a small biotech differs from running an audit program inside a large drug company. Also decide whether your question is about audits of sites and vendors, inspection readiness or quality systems, and ask which of these the person has owned directly.
Questions to take into the conversation
- 01How do you decide which clinical sites and vendors to audit, and how often?
- 02What does inspection readiness look like in the months before a regulator visits, and where do sponsors usually fall short?
- 03How do you oversee the quality of work done by contract research organizations without duplicating their effort?
Reaching GCP quality assurance experts
How can I contact one of these GCP quality assurance experts?
Pick one of the 10 people on this page and choose "Book a paid call", or describe your project to find others. You offer a fee for a 15-minute call or a written answer, Instant Expert finds the person's work email and sends the invitation, and they decide whether to accept. The list covers 10 companies, including Nuvalent, Inc.; Mirum Pharmaceuticals, Inc. and Aeglea BioTherapeutics, based on profile data retrieved on October 4, 2026. Being listed here doesn't mean someone has agreed to take calls.
How much does it cost to reach GCP quality assurance experts?
You choose the offer, starting at $5 per person. It includes Instant Expert's 20% fee, so an offer that pays the person $100 costs you $125. You're charged only when the person books the call or sends the answer.
What if they don't reply?
You pay nothing. Instant Expert sends follow-up reminders, and if the person hasn't booked or answered within 7 days, the request expires and any hold on your card is released. You can invite several of the 10 people on this list at once and cap your total spend, so you pay only for the ones who accept.
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot and may describe past or present roles. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.
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