Site Quality Director

1 week ago

Skipton, North Yorkshire, United Kingdom Dechra Full time

Job Introduction

We are seeking a highly skilled and experienced Quality Director to join our team at Dechra. As a global specialist in veterinary pharmaceuticals, we are committed to delivering high-quality products and services to our customers.

The successful candidate will be responsible for managing the Quality teams on site, including Quality Control, Quality Assurance, and Qualified Persons. They will ensure that quality standards and systems are implemented and maintained in compliance with UK, EU, and FDA cGMP.

This is a challenging and rewarding role that requires strong leadership and technical skills. The ideal candidate will have extensive knowledge of GMP, UK, EU, and FDA regulations, as well as experience in devising, implementing, and maintaining pharmaceutical quality systems.

The Opportunity

The Quality Director will be responsible for:

  • Providing strong leadership of the quality team at Skipton, demonstrating maturity, integrity, experience, and knowledge of the subject.
  • Building and encouraging positive relationships across site functions to ensure support and collaboration in raising quality standards.
  • Designing, developing, and implementing a sustainable quality strategy for the site, including resource, system, or investment requirements with clear milestones to demonstrate progress.
  • Planning and managing departmental activities and resource in accordance with agreed budgets and timescales and standards.
  • Driving performance improvements across departments, recognizing efficiencies while driving continuous quality improvement.
  • Risk Management: Ensuring strategic quality risk management activities are implemented and enabling identification, mitigation, and/or escalation of risks for items that could adversely impact quality compliance associated with projects/systems.
  • Coordinating with regulatory Authorities (VMD, FDA, etc.) including product recalls, license application/variation, defect reporting, annual controlled drugs return process.
  • Using departmental KPIs to monitor and improve performance (in relevant areas) according to agreed standards and taking necessary action to communicate/advise/assist according to performance levels.
  • Ensuring the Quality function operates aligned to the 5 strategic pillars across the site and wider DPM&S division (People, Safety, Quality, Deliver & Cost).
  • Supporting the development of the quality team by mentoring and coaching team members to improve their knowledge and secure succession plans.
  • Liaising with regulatory bodies and site departments to ensure compliance to current standards.
  • Liaising with customers and suppliers with respect to quality aspects in supporting existing business and new product introductions.
  • Supporting the implementation of new initiatives including systems and processes, to ensure new ways of working are implemented and compliance maintained.
  • Establishing and implementing necessary communication strategy for the improvement and awareness of quality issues across all departments.
  • Troubleshooting and being able to think laterally and contribute technically to manufacturing and testing issues as they arise.
  • Reporting as necessary on changes in standards (internally and externally initiated) and on performance against standards.
  • Providing feedback on quality performance and Quality KPIs at the appropriate forums.
  • Hosting both Regulator and Customer audits.
  • Conducting supplier audits as necessary.
  • Liaising with Internal Network Quality Director to ensure consistency and continuity of projects across Dechra Manufacturing, and deputising where required.

The Ideal Candidate

We are an inclusive employer and welcome candidates from all walks of life. The ideal candidate will be:

  • 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 pharmaceutical 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 Quality Control laboratories.
  • Eligibility for QP status is highly desirable.
  • Occasional global travel is required with this role.

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