Site Quality Director
4 weeks ago
About Dechra
Dechra is a global specialist in veterinary pharmaceuticals, dedicated to developing, manufacturing, marketing, and selling high-quality products exclusively for veterinarians worldwide.
Our Culture
Our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships, and (A)mbition are at the heart of our everyday operations and the way we do business.
The Opportunity
We are seeking a highly skilled and experienced Site Quality Director to join our team at our Skipton manufacturing facility. As a key member of our quality team, you will be responsible for ensuring that our quality standards and systems are implemented and maintained in compliance with UK, EU, and FDA cGMP.
Key Responsibilities
- Provide strong leadership of the quality team at Skipton, demonstrating maturity, integrity, experience, and knowledge of the subject.
- 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 resource, system, or investment requirements with clear milestones to demonstrate progress.
- Plan and manage departmental activities and resource 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 application/variation, defect reporting, annual controlled drugs return process.
- Use departmental KPIs to monitor and improve performance (in relevant areas) according to agreed standards and take necessary action to communicate/advise/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 to current standards.
- Liaise with customers and suppliers with respect to 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 strategy for the improvement and awareness of quality issues across all departments.
- Troubleshoot and be able to think laterally and contribute technically to manufacturing and testing issues as they arise.
- Report as necessary on changes in standards (internally and externally initiated) and on performance against standards.
- Provide feedback on quality performance and Quality KPIs at the appropriate forums.
- Host both 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
- 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 Quality Control laboratories.
- Eligibility for QP status is highly desirable.
- Occasional global travel is required with this role.
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