Quality & Compliance Lead (RP)

Uniphar and Durbin Background

Uniphar group is a rapidly expanding global healthcare services business with a proud heritage in Ireland.  Since IPO in 2019, the group has grown both organically and through a series of strategic acquisitions including Durbin Plc in 2020, which continues to strengthen Uniphar’s international reach. With a workforce of close to 3000 employees spread across Ireland, United Kingdom, Netherlands, Nordics, and the USA, Uniphar is a trusted global partner to pharma and medtech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams.  Uniphar is organised into three key divisions; Supply Chain & Retail, Commercial & Clinical Med Tech / Pharma; and Product Access.

Culture at Durbin and parent company Uniphar

Ethics and integrity sit at the heart of our culture, with our customers and patients integral to what we do and how we do it.  We pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos.  Everything Uniphar does is enabled by our people and as we continue to grow domestically and internationally, we become more diverse.  This diversity fuels our business and culture. 

The Role

The Quality and Compliance Lead (RP and RPi) is an integral member of the UK Quality Team, dealing with GDP aspects for Suppliers and Customers, Import and Export of licensed and unlicensed Medicines, Medical Devices and other Healthcare products. Tasks vary greatly from day to day and the incumbent will be expected to organize their own workload and provide management and guidance to a small team of Quality colleagues.

Key outcomes

Partner with the UK Head of Quality to deliver a strategy for the quality function for the UK business including:

• Building a best-in-class quality team and creating a high-performance quality culture across all functions within the business
• Create an environment of right first time in everything that we do
• Act as RP on UK WDA(H) licence
• Promote a culture of quality achievement and performance improvement across the business whilst ensuring compliance with national and international standards and legislation
• Lead QA related projects
• Ensure that all SOP’s are clearly defined and integrated within the wider business and are supporting the day-to-day operations of the business
• Customer/supplier approval and categorization of products allowed according to licensure
• Management of customer complaints, deviations, CAPAs and change management
• Conduct Quality Management Review meetings
• Management of product recalls and returns
• Outsourced activities assessment and approval
• Management and supervision of relevant members of the Quality assurance team
• Perform internal and external audits
• Act as a QC on MS licence

Key Skills & Experience (broad where possible)

Essential:

• Previous RP experience on WDA(H) with export condition
• Proven experience of working within quality assurance in pharma industry
• Experience in supervising a small team – preferably two people or more.
• Experience in QMS, handling change controls, CAPA, deviations, risk assessments.
• Experience in Internal/external auditing of GDP Quality systems.
• Essential PC skills, including Microsoft Office, Excel, and Outlook.
• Ability to quickly adapt to the new processes and various IT systems.
• Excellent organizational skills.
• Adapt to working under pressure in a fast-paced environment.
• Knowledge and understanding of storage and distribution of pharmaceuticals under GDP.

Desirable:

• Eligibility to act as Responsible Person Import (RPi)
• Experience in working with Unlicensed medicinal products.