Kate has over 20 years’ experience in Quality Assurance, Sterility Assurance, Microbiology and Quality Control, and has worked across ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs and Oral Dose platforms.
The prestigious senior appointment comes as ambitious ATMP/innovative product companies continue to choose Arriello for holistic Regulatory/Quality services adapted to clients’ needs.
Dublin, Ireland – September 20th , 2023
Arriello, a leading provider of integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services, has announced that industrial microbiology and quality risk management specialist Kate Coleman, will join the company in September as VP of Quality & Compliance. She joins from PharmaLex, where she was Senior Director/Principal Consultant for Quality Management and Compliance and QMC Head of the UK/Ireland region.
Kate brings two decades of experience to the senior role at Arriello, having worked within the industry at brands including Sanofi (where she spent 9 years across roles including Quality Assurance, Sterility Assurance Lead and QC Microbiology Team Leader); Wyeth Biopharma; and EirGen Pharma. She moved into consulting at PharmaLex at the end of 2017. Her work has spanned ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs and Oral Dose platforms.
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:
- The 2023 RQA International QA Conference hosted by the Research Quality Association (therqa.com) in Belfast from November 1-3, for which Arriello is a Silver sponsor. Here she will present on the theme of “QRM and Quality – Making sure fear doesn’t undermine your QRM programme” – exploring the purpose of Quality Risk Management.
- The PDA (Parenteral Drug Association)/Ireland Chapter Microbiology Conference in Dublin on November 23.