Director of Quality

Leading Pharmaceutical Development and Manufacturing Company based in Northumberland seeks an experienced Director of Quality.

About the role:

The role has responsibility for acting as an associate of the EU Quality function in terms of implementing business goals and processes including delivery/implementation of CQA initiatives, CQA Policies/Guidelines and the CQA Audit programme, at a site level.

Duties may include:

• To collaborate with Site Leadership team and all department heads to ensure regulatory compliance, cGMP and quality assurance are a shared responsibility.
• To ensure an effective Quality function at the site, facilitating the long and short–term business aims and objectives.
• To manage and host all regulatory and strategic customer audits.
• To be an effective associate of the Regional Quality team, taking part in CQA initiatives as needed.
• Identification, remediation and escalation of all compliance issues with the potential to cause critical or major audit observations from the site, to the UK & EU Regional Quality Director.
• Ensure the Pharmaceutical Management System, Quality resource and capabilities available at the site supports the delivery of projects and new business.
• Manage the Quality Management Review process and appropriate action plans, including functional escalation
• Lead innovation and improvements of processes in relation to the Pharmaceutical Quality Systems employed.
• Ensure all activities comply with the requirements of the manufacturing and distribution licenses, national and international guidelines appropriate to the destination market, marketing authoritarians and Clinical Trial Authorizations.
• Ensures adherence of all cooperate guidelines and ESH requirements
• Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation
• Senior management's leadership and active participation in the Pharmaceutical Quality System is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality System.
• There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself.
• The Pharmaceutical Quality System should be defined and documented. A Quality Manual or equivalent documentation should be established and should contain a description of the quality management system including management responsibilities.

Skills and experience:

• Degree in relevant scientific/technical discipline
• Ability to act as a QP in accordance with either the Human Medicines regulations or EU directive 2001/83/EC is preferred but not essential
• Must have extensive knowledge of Quality Assurance systems in the pharmaceutical industry.
• Relevant senior management experience within an EU/FDA approved pharmaceutical facility, including; experience of hosting regulatory inspections (specifically MHRA and USFDA) and customer audits, Championing a culture of compliance and driving continuous improvement.
• An understanding of framework and interdependencies of regulatory affairs and validation.