Head of Quality
Do you have a passion for Quality?
Are you looking for your next role within the biotech industry? If yes, then we want to hear from you!
My client is looking for a Head of Quality and Regulatory to join their team in Glasgow.
They are recognized leaders in cell line and process development and well as a leading provider of contract testing services to the global biopharmaceutical and biotechnology industries.
The successful candidate will be responsible for the Regulatory compliance of all sites to the appropriate FDA, EU and local requirements.
Mainly you will be maintaining their regulatory licenses (MA(IMP) ensuring that GMP, GLP and GCP compliance is maintained throughout the GxP testing facilities and cell bank manufacturing site.
You'll need to develop and implement a shared Quality framework across all sites, so designing and implementing QMS systems will be second nature to you and you'll be able to promote and maintain a quality culture throughout the organisation.
A big part of the role will be to Lead, develop, and recruit high performing Quality teams with appropriate regulatory knowledge. Additionally, you'll be able to provide expert guidance and leadership on items relating to cGMP compliance, including compliance to Corporate Standards, Internal and External audits, processes, validation, process media simulations and process interventions and deviations as well as Hosting Regulatory Inspections and liaising with regulatory bodies (eg MHRA, FDA etc) as required.
The successful candidate will have proven practical application of regulatory directives especially Directive 2001/83/EC, 2003/94/EC, 2011/62/EU and 2001/20/EC. You'll have a thorough understanding of pharmaceutical production technologies, QC procedures, and regulatory requirements as well as being extremely organised and possessing the ability to prioritise multiple tasks and have the confidence to challenge existing systems & processes.
If you would like to find out more about this role, then get in touch today and apply below.