Integrated Regulatory Affairs, Pharmacovigilance and Auditing & QA solutions and services
leader, Arriello (https://www.arriello.com) appoints biotech expert Kate Coleman as Vice
President of Quality and Compliance. Joining from PharmaLex, Coleman brings two decades of
experience of ATMPs, Biologics, Sterile Fill Finish, Vaccines, APIs, and Oral Dose platforms to the senior role at Arriello, having work within the industry at brands including Sanofi (where she spent nine
years across roles including Quality Assurance, Sterility Assurance Lead and QC Microbiology Team Leader); Wyeth Biopharma; and EirGen Pharma.
“At Arriello I see a real opportunity to keep building the Quality function, collaboratively with the team, in response to the evolving challenges in the market. Arriello has the advantage of being very dynamic – able to turn on a dime, and deliver what customers really need and want today,” says Kate Coleman, Vice President of Quality and Compliance.
“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. 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.”
Coleman’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. I’m particularly interested in the interdependence of Regulatory and Quality,” she adds. “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.”
“We’re absolutely delighted to welcome Kate to the team,” says Anna Lukyanova, Chief Operating Officer and Co-founder, Arriello. “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.”
Coleman 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 1-3 November 2023, 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, and at The PDA (Parenteral Drug Association)/Ireland Chapter Microbiology Conference in Dublin on 23 November 2023.
Holding 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, Coleman 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 Authorization, or that these have undergone comprehensive analysis if imported from elsewhere.)