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Site Quality Director
2 months ago
About the Role
We are seeking a highly skilled and experienced Quality Director to join our team at Dechra. As a key member of our site leadership, you will be responsible for the management of the Quality teams, ensuring that our quality standards and systems are implemented and maintained in compliance with UK, EU, and FDA cGMP.
Key Responsibilities
- Provide strong leadership to the quality team, 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, and 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.
About You
We are looking for a highly motivated and experienced individual who has a strong background in quality assurance and regulatory compliance. You will have a proven track record of working with multi-department projects and have experience in devising, implementing, and maintaining pharmaceutical quality systems compliance with UK, EU, and FDA GMP requirements.
Requirements
- 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.
What We Offer
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced individual who is passionate about quality assurance and regulatory compliance, we encourage you to apply for this exciting opportunity.
