Lynne Byers has gained more than 35 years’ of extensive pharmaceutical manufacturing management and QA experience working for three major international pharmaceutical manufacturers, culminating in the role of Global Head (VP) of External Supply Operations QA for Novartis in Switzerland. In addition, she worked as Head of Inspectorate and Licensing for the MHRA from 2004-2006. She joined NSF in 2017.
Ms. Byers has broad experience in manufacturing management and QA of a wide range of sterile and non-sterile dosage forms, and is fully conversant with current EU and FDA GMP regulations and requirements. She has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers who are suppliers to the pharmaceutical industry worldwide. She also has extensive experience in managing QA teams in country affiliates.
Ms. Byers is eligible to act as a Qualified Person and was a QP assessor on behalf of the Royal Society of Chemistry from 1999 to 2004. During her tenure with the MHRA she was responsible for agreeing to QPs being named and removed from manufacturing authorizations.
Areas of recognized expertise include:
- QP training
- Packaging and labeling control
- GMP legislation
- API manufacture and control
- Auditing and self-inspection skills – Education of auditors
- Supply chain distribution
- Quality management of pharmaceutical suppliers
- Quality management of contract manufacturers
- Affiliate quality assurance