Nollaig Buckley has over 18 years of experience as a contract Qualified Person across investigational and commercial product licenses covering solid oral dosage and sterile products. She was also contract Head of Quality for more than 3 years for a San Francisco based, clinical-stage, biopharmaceutical company headquartered in Dublin, Ireland. Nollaig held a range of Technical/Validation roles with Elan Pharmaceuticals and also held positions in API development at Pharmacia Upjohn.
As a consultant, Nollaig has served clients ranging from small development solid oral dosage and biotech companies to larger commercial-stage companies. She has consulted for these clients in the area of Quality Management Systems, GMP Compliance, and has provided QA support for product/process development and process validation/characterization activities. In her role as the contract Head of Quality she released a range of biologics batches to US clinical trials on behalf of the sponsor client, and supported CMC, clinical and non-clinical activities in the US. Throughout her career, Nollaig has gained significant EU and US knowledge in Quality, Technical, Compliance, and Regulatory challenges. She has also lead manufacturing sites through competent authority audits.
At Cilatus, Nollaig is a key team member of the Cilatus QP Service and QP Certification business, Cilatus Manufacturing Services Ltd., based in Dublin, Ireland.