Emma Newman, Global Quality Assurance IS Compliance

Job title: Global Quality Assurance IS Compliance
Employer: Shire Pharmaceuticals

Qualifications: 

• BSc 1st Class (Hons) Electronic Marine Navigation and Marine Law

Institutions:

• British Association of Research Quality Assurance
• Chartered Quality Institute, MCQI CQP

Career path:

• IT trainer, Vodafone
• IT trainer/Software Tester, Dendrite
• European Quality Manager for Software tester, Dendrite
• Quality Manager, Laleham Healthcare
• Corporate Quality Assurance, Shire Pharmaceuticals

What does your current role involve?

My role is to ensure that all software projects that have the potential to impact patient safety, product quality or efficiency are managed to ensure there is no risk and that compliance to all regulatory requirements is maintained. This means constantly reviewing or preparing protocols and validation plans. It is also my job to audit potential suppliers to ensure that we do not introduce risk into our organisation from outside.
 
I am constantly trying to balance the requirement for compliance with the cost of achieving it, taking into account the needs of the regulators and the business and project managers. 

What’s great about being a quality professional?

Knowing that what you are doing adds real value to the business. I enjoy demonstrating how to apply the quality culture to IS projects while also working with the project timeline and budget constraints. I love it when challenges arise and when quality tools, techniques and attitude can actually find a solution.

How did you get into quality?

I worked in a pharmaceutical customer relationship management software company as the training manager. I quickly learnt that it was best to test new bespoke software before training! The tester/trainer role soon evolved into two distinct roles and I trained as an Software Tester and headed up the new software testing group as the European QA Manager. 

I moved from software into a fast moving consumer goods contract manufacturing and packaging, which gave me insight into the factory quality assurance culture. I joined Shire’s Corporate in 2005 and was initially responsible for liaising with external contract manufacturers. Recently I have joined the newly formed IS compliance group.

Any tips for pursuing a quality career?

Quality tools and techniques are transferable between industries and much can be learnt from talking to other quality people outside your industry sector. Quality people can be seen as barriers, but open discussion, respect and a willingness to try to find a pragmatic solution can allow the quality message to be understood - even by the most reluctant individual.