Lowe joins senior team at Arriello
Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services provider, Arriello (www.arriello.com) announces the appointment of leading GVP Audit and Quality Assurance (QA) expert Helen Lowe to its rapidly-expanding global Quality & Pharmacovigilance operations.
Based in the Isle of Man and working as part of Arriello’s Irish operations, Lowe brings two decades of experience to the role as Arriello’s new Auditing & QA Director. During an illustrious career to date Lowe has worked at the heart of the life sciences industry, in drug safety roles at Mayne Pharma, Bristol-Meyers Squibb, Johnson & Johnson and Biogen, before becoming an independent GVP consultant and then moving into third-party service provision with remits spanning quality assurance and auditing.
Her experience spans pharmaceutical R&D, quality assurance, PV and clinical site auditing, quality management systems (QMS), clinical drug development, post marketing drug safety /PV, and regulatory compliance. Lowe has a strong track record of participating in and managing/hosting numerous health authority inspections (including FDA, BfArM, MHRA, AEMPS), in undertaking mock inspections, providing inspection readiness training / support and performing gap analysis assessments, and is an active member of the Research Quality Association (RQA).
Welcoming Helen to Arriello, Alan White, CEO at the company, said: “We are thrilled to have such deeply experienced QA and PV talent joining the business, and delighted for our clients – current and future – who will feel the benefit of all of this additional experience and expertise. I would like to extend a very warm welcome to Helen, whose contribution to our future success is much anticipated.”
Commenting on her move to Arriello, Helen says, “Arriello is a service provider with big ambitions, which still retains a culture of being very personable and approachable for clients that need its support. The company has an impressive knowledge base, and the chance to expand and build on its Auditing and QA service operations was very appealing. I very much relish this new challenge.”