Quality Director
Location: Oxfordshire
Salary: Highly Competitive + Car Allowance + Bonus
We are working with a major pharmaceutical manufacturing business to recruit an experienced Quality Director to lead and develop its site Quality function.
This is a senior leadership position within a substantial pharmaceutical operation, with responsibility for a large team covering Quality Assurance, Qualified Persons and wider Quality Operations.
The successful candidate will work closely with senior site leadership, providing strategic direction on quality, compliance and regulatory matters while ensuring the site continues to meet the highest standards of pharmaceutical manufacturing.
The Role
• Provide overall leadership and direction for the site Quality function, including QA, Qualified Persons and customer-facing quality activities.
• Lead and develop a sizeable team of quality professionals, including managers and senior technical specialists.
• Maintain robust pharmaceutical quality systems and ensure compliance with applicable GMP requirements and regulatory standards.
• Provide strategic oversight of deviations, investigations, CAPAs, change control, complaints, risk management, documentation and product quality reviews.
• Take a leading role in regulatory inspections and maintain strong relationships with regulatory authorities and external customers.
• Work closely with Manufacturing and Operations leadership to support business priorities while maintaining quality and compliance.
• Drive continuous improvement across the site, improving right-first-time performance, investigation effectiveness, batch release processes and overall quality performance.
• Develop a strong quality culture, promoting accountability, engagement and continuous improvement throughout the organisation.
• Provide leadership, coaching and development to build a capable and effective Quality organisation, including succession planning and future capability.
About You
• Significant experience in pharmaceutical Quality leadership within a GMP-regulated manufacturing environment.
• A proven track record of leading sizeable Quality teams within a complex pharmaceutical operation.
• Strong knowledge of pharmaceutical quality systems, manufacturing oversight, batch disposition and regulatory compliance.
• Experience working with major regulatory authorities, including MHRA, FDA and EMA.
• Able to operate at both strategic and operational levels, influencing senior stakeholders and providing clear direction to wider site teams.
• Strong leadership skills, with the ability to develop managers, technical specialists and wider Quality teams.
• Degree qualified in a relevant scientific discipline such as Chemistry, Pharmacy or Biology, or equivalent experience.
Qualified Person (QP) status is highly desirable, and eligibility to act as a named QP would be a significant advantage.
Experience in solid dose pharmaceutical manufacturing would also be beneficial.
The Opportunity
This is an opportunity to take on a high-profile Quality leadership position within a major pharmaceutical manufacturing operation, with significant responsibility, a substantial team and the opportunity to influence quality strategy and site performance.
The package is highly competitive and will reflect the experience and suitability of the successful candidate, alongside a car allowance and bonus.
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us
