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Site Quality Director: Leadership Excellence in Pharmaceutical Manufacturing

1 month ago


Skipton, North Yorkshire, United Kingdom Dechra Full time
About Dechra

We are a growing global specialist within the world of veterinary pharmaceuticals. Our expertise lies in the development, manufacture, marketing, and sales of high-quality products exclusively for veterinarians worldwide.

Job Overview

This role offers an exciting opportunity to lead our quality teams on-site, ensuring that we maintain the highest standards of quality compliance with UK, EU, and FDA cGMP regulations.

Responsibilities
  • Provide strong leadership to the quality team at Skipton, demonstrating maturity, integrity, experience, and knowledge of subject matter.
  • BUILD AND ENCOURAGE POSITIVE RELATIONSHIPS ACROSS SITE FUNCTIONS TO ENSURE SUPPORT AND COLLABORATION IN RAISING QUALITY STANDARDS.
  • Design, develop, and implement a sustainable quality strategy for the site, including any resource, system, or investment required, with clear milestones to demonstrate progress.
  • Plan and manage departmental activities and resources in accordance with agreed budgets and timescales and standards.
  • Drive performance improvements across departments, recognizing efficiencies while driving continuous quality improvement.
  • Risk Management: Ensure strategic quality risk management activities are implemented and enable identification, mitigation, and/or escalation of risks for items that could adversely impact quality compliance associated with projects/systems.
  • Coordinate with regulatory authorities (VMD, FDA, etc.), including product recalls, license applications/variations, defect reporting, and annual controlled drugs return processes.
  • Use departmental KPIs to monitor and improve performance according to agreed standards and take necessary action to communicate/advice/assist according to performance levels.
  • Ensure the quality function operates aligned to the 5 strategic pillars across the site and wider DPM&S division (People, Safety, Quality, Deliver & Cost).
  • Support the development of the quality team by mentoring and coaching team members to improve their knowledge and secure succession plans.
  • Liaise with regulatory bodies and site departments to ensure compliance with current standards.
  • Liaise with customers and suppliers regarding quality aspects in supporting existing business and new product introductions.
  • Support the implementation of new initiatives, including systems and processes, to ensure new ways of working are implemented and compliance maintained.
  • Establish and implement a communication strategy for the improvement and awareness of quality issues across all departments.
  • Troubleshoot and think laterally to contribute technically to manufacturing and testing issues as they arise.
  • Report on changes in standards (internally and externally initiated) and on performance against standards.
  • Provide feedback on quality performance and quality KPIs at appropriate forums.
  • Host regulator and customer audits.
  • Conduct supplier audits as necessary.
  • Liaise with Internal Network Quality Director to ensure consistency and continuity of projects across Dechra Manufacturing and deputise where required.
Requirements
  • 'Due to the nature of our business, all successful candidates will be required to complete a basic DBS check (Disclosure and Barring Service check) before employment can commence, and at regular intervals during employment. This check will be paid for by Dechra.'
  • Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy.
  • Fully IT-literate: Microsoft Outlook, Word, Excel.
  • Ability to prioritise work and handle multiple deadlines.
  • Extensive knowledge of GMP, UK, EU, and FDA.
  • Extensive demonstrated pharmaceutical quality experience, including audit, batch record review, change control, complaint handling, and investigations experience.
  • A thorough knowledge of pharmaceutical/nutraceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
  • Experience of hosting UK and FDA inspections, client audits, and self-inspections.
  • Experience in devising, implementing, and maintaining pharmaceuticals quality systems compliance with UK, EU, and FDA GMP requirements.
  • Technical knowledge to support quality and validation decision-making.
  • Proven track record of working with multi-department projects.
  • Degree in Chemistry or equivalent, or significant understanding/experience in Quality Control laboratories.
  • Eligibility for QP status is highly desirable.
  • Occasional global travel is required with this role.
Salary Range

£60,000 - £80,000 per annum, depending on experience, plus benefits and bonuses.