Kate holds a BSc Hons degree in Industrial Microbiology from University College Dublin, an MSc in Pharma Quality Assurance/Pharma Sciences from Dublin Institute of Technology, and a Post-Grad Diploma in Manufacturing Technology (QP)/Pharma Sciences from Trinity College Dublin. This last accomplishment, gained in 2009, means Kate can act as a Qualified Person (QP) for clients in the EU. (A QP is a named individual who is responsible for ensuring that each batch of product has been manufactured in compliance with national laws and the requirements of the Marketing Authorisation, or that these have undergone comprehensive analysis if imported from elsewhere.)
On her decision to join Arriello, Kate said: “I know someone at the company who is very enthusiastic about what a great place to work Arriello is, with lots of opportunity and a strong culture. I particularly wanted to work for a boutique consultancy, where I can support the internal Quality team and continue to engage face to face with clients and provide bespoke support for their challenges, something I really appreciate.
“At Arriello I see a real opportunity to keep building the Quality function too, collaboratively with the team, in response to the evolving challenges in the market,” she continued. “Arriello has the advantage of being very dynamic – able to turn on a dime, and deliver what customers really need and want today.
“The whole pharma market is changing at speed, with an emphasis on advanced and novel/cell and gene therapies, giving rise to a whole raft of innovative new products,” Kate explained. “The challenge, though, is that there is no black and white guidance for how to ensure compliance in these novel areas, when compared to traditional drugs and decisions need to be based on risk. I have particular expertise here which I look forward to bringing to bear for Arriello’s clients.”
Kate’s career path in Ireland to date has given her particular experience of supporting rapid growth, and the design and start-up of greenfield sites. “This, coupled with my biologics background, means I’m well positioned to support pharma and biotech companies as they grow and expand,” she noted.
“I’m particularly interested in the interdependence of Regulatory and Quality,” she added. “As companies develop their strategies and processes, it’s especially important that they are able to look holistically at what they need rather than operating in silos – and Arriello’s service strategy is very much about that integrated offering.”
Welcoming Kate to the company, Anna Lukyanova, Arriello’s COO and co-founder, said: “We’re absolutely delighted. Kate is deeply experienced and well respected in fields that are extremely important to us and to our clients, and we share Kate’s excitement about the potential to build a highly positive offering that is valued by customers both now and in the future – in what is a very changeable market. Not only has Kate served as a practising QP, Principal Consultant, and qualified Lead Auditor; she is also a subject matter expert in Risk Management, New Facility Design/Start Up, Quality Control and Sterility Assurance. All of these areas are of immense value to Arriello’s clients.”
Kate, who will join Arriello in mid-September, will make her mark immediately with key speaking engagements and involvement at:
About Arriello
Arriello is a leading consultancy and solutions provider of risk management and compliance services to the pharmaceutical industry. We’ve been making the development-to-market process faster, better, and smarter since 2008.
Our global services span the product lifecycle from Clinical to post-submission Regulatory Affairs and Pharmacovigilance, Quality Assurance and Auditing, and innovative automation solutions.
Headquartered in Ireland, with operations across Europe, we consult and create solutions across the EU, North America, LATAM, CIS, MENA, Asia, and South Africa.
With our extensive global network, decades of combined experience and ISO:9001 certification, we are a trusted partner primarily to pharmaceutical and biotech companies.
Our valued clients rely on our ability to deliver, however complex their requirements, through our proven expertise, global coverage, and technology. More at www.arriello.com
Media contact:
Carina Birt
Sarum PR for Arriello
[email protected]
+44 7970 006624
Media Contact
Chris Slack, Arriello, 44 1747830606, [email protected], https://arriello.com/
SOURCE Arriello
