Site Quality Director

6 days ago

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

We are seeking a highly experienced and skilled Site Quality Director to join our team at Dechra. As a key member of our leadership team, you will be responsible for ensuring the highest standards of quality across our site, including Quality Control, Quality Assurance, and Qualified Persons.

Main Responsibilities
  • Provide strong leadership and guidance to the quality team, demonstrating expertise and knowledge of pharmaceutical quality systems.
  • Build and maintain positive relationships with site functions to ensure collaboration and support in raising quality standards.
  • Design, develop, and implement a sustainable quality strategy for the site, including resource planning and investment.
  • Plan and manage departmental activities and resources in accordance with agreed budgets and timescales.
  • Drive performance improvements across departments, recognizing efficiencies while driving continuous quality improvement.
  • Ensure strategic quality risk management activities are implemented and enable identification, mitigation, and/or escalation of risks.
  • Coordinate with regulatory authorities, including product recalls, license applications, and defect reporting.
  • Monitor and improve performance using departmental KPIs, taking necessary action to communicate and advise according to performance levels.
  • Ensure the Quality function operates aligned to the 5 strategic pillars across the site and wider DPM&S division.
  • Support the development of the quality team through mentoring and coaching.
  • Liaise with regulatory bodies and site departments to ensure compliance to 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 necessary communication strategies for the improvement and awareness of quality issues across all departments.
  • Troubleshoot and contribute technically to manufacturing and testing issues as they arise.
  • Report on changes in standards and performance against standards.
  • Provide feedback on quality performance and Quality KPIs at appropriate forums.
  • Host regulator and customer audits, conduct supplier audits as necessary, and liaise with the Internal Network Quality Director.
Ideal Candidate

We are looking for a proactive and solutions-driven individual with extensive knowledge of GMP, UK, EU, and FDA regulations. The ideal candidate will have:

  • Proven experience in pharmaceutical quality, including audit, batch record review, change control, complaint handling, and investigations.
  • A thorough knowledge of pharmaceutical/nutraceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
  • Experience in hosting UK and FDA inspections, client audits, and self-inspections.
  • Experience in devising, implementing, and maintaining pharmaceutical quality systems compliance with UK, EU, and FDA GMP requirements.
  • Technical knowledge to support quality and validation decision-making.
  • A proven track record of working with multi-department projects.
  • Eligibility for QP status is highly desirable.

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