We’re seeking a proactive and strategic Quality Director to oversee our Quality function activities across our Barnstaple manufacturing site, ensuring processes are effective, efficient and compliant to all current and future MHRA and EU/US GMDP standards. Leading a team of c. 90 employees across our QC and QA departments, you’ll manage the strategic and operational performance of the team to deliver business strategy, KPIs and objectives, supporting Regulatory compliance and Commercial success. Acting as the primary interface with the MHRA and other Competent Authorities, you’ll lead GMDP inspections and audits, you’ll also take responsibility for the Barnstaple Quality budget to ensure appropriate resource is available, as required. Working with departments across the business to provide QA input, you’ll instil a ‘Quality first’ culture for all employees, identifying training plans for the business and development opportunities for your team, whilst proactively identifying areas / activities to minimise any potential Quality risks with a focus on protecting patients.
To support the smooth running of the Quality department across the business, you’ll work closely with the EMENA Quality Leadership Team to ensure a consistent and compliant approach with EU GMDP requirements, and support wider Supplier Quality, Regional Audit and Good Distribution Practice activities. Working as a team, you’ll identify continuous improvement opportunities to develop and simplify our pharmaceutical Quality Management Systems, and regularly provide performance data to review operational effectiveness, product safety and to drive efficiencies. In addition, you’ll perform Qualified Person duties (in accordance with Directive 2001/83/EC) and Responsible Person (import, RPi) activities, as required.