NSF International has appointed Lynne Byers as executive director and David Waddington as director of its pharmaceutical biotech services in Europe.
In her role, Lynne Byers oversees consulting, auditing, and training services for a variety of pharmaceutical operations in Europe. She also provides strategic consulting and training services, while assisting clients to establish and implement remediation plans to address audit findings and regulatory actions.
Byers brings more than 35 years of extensive pharmaceutical manufacturing management and quality assurance (QA) experience to NSF International’s pharmaceutical biotech business, including manufacturing management and QA for a wide range of sterile and non-sterile dosage forms.
Prior to joining NSF International, she was the global head (VP) of external supply operations QA for Novartis in Switzerland. She also worked as head of inspectorate and licensing for the Medicines and Healthcare Products Regulation Agency (MHRA), where she was responsible for the manufacturing authorisations of qualified persons (QP).
Byers’ international experience includes QA auditing of pharmaceutical manufacturers who are suppliers to the worldwide pharmaceutical industry, and the management of QA teams in country affiliates. She is fully conversant with current EU and US Food and Drug Administration (FDA) good manufacturing practice (GMP) regulations and requirements, and is eligible to act as a QP, having served in the role of QP assessor on behalf of the Royal Society of Chemistry from 1999 to 2004.
Byers is a Fellow of the Royal Society of Chemistry and a Member of the Pharmaceutical Quality Group.
In his new position, David Waddington’s responsibilities include the establishment, promotion, and growth of NSF International’s consulting, auditing, and training services in Europe. In addition, he is the key account manager in the development and maintenance of business relationships.
Waddington comes to NSF International’s pharmaceutical biotech team with more than 30 years of experience in a variety of roles for three major international pharmaceutical organisations.
His most recent appointment prior to NSF International was quality director of global regulatory compliance for Catalent Pharma Solutions. Waddington also has extensive experience in QA auditing of pharmaceutical suppliers and manufacturers in Europe, North America, and the Asia-Pacific.
He is fully conversant with current EU and FDA GMP regulations and requirements, and is eligible to act as a QP under the permanent provisions. Waddington is a Member of the Royal Society of Chemistry and a Member and Secretary of the Pharmaceutical Quality Group.
Executive vice-president of pharmaceutical biotech at NSF International Mike Halliday said: “Both Lynne and David bring a wealth of experience to NSF International’s pharma biotech service and we are thrilled to have them on board. Our group is very team-focused and it is a pleasure to welcome Lynne and David to the team. In just a few weeks they have settled in brilliantly and are already working with key clients to protect patients and businesses worldwide.”