Site Quality Director
2 months ago
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.
Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, 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
Responsible for the management of the Quality teams on site including Quality Control, Quality Assurance and Qualified Persons.
To ensure that the quality standards and systems are implemented and maintained in compliance with UK, EU and FDA cGMP.
This role will be fully onsite at our Skipton manufacturing facility, but does have the benefit of a 9 day working fortnight.
Role Responsibility
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
Provide strong leadership of the quality team at Skipton demonstrating maturity, integrity experience and knowledge of subject. Build and encourage positive relationships across the site functions to ensure support and collaboration in raising quality standards. Design, develop and implement a sustainable quality strategy for the site. Plans should include any resource, system or investment required 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 the departments, recognising 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.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:
‘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. 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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