About EIT:
The Ellison Institute of Technology (EIT) Oxford’s purpose is to have a global impact by fundamentally reimagining the way science and technology translate into end-to-end solutions and delivering these solutions in programmes and platforms that respond to humanity’s most challenging problems.
EIT Oxford will ensure scientific discoveries and pioneering science are turned into products for the benefit of society that can have high-impact worldwide and, over time, be commercialised to ensure long-term sustainability.
Led by a faculty of world experts, EIT Oxford seeks to solve the world’s most challenging problems across four high-risk, high-reward, high-impact humane endeavours: health and medical science; food security and sustainable agriculture; climate change and clean energy; and government innovation in an era of artificial intelligence.
EIT Oxford is investing significant resources in a new world-class research and development facility in the Oxford Science Park. Set for completion in 2027, the state-of-the-art campus includes 300,000 sq ft of research laboratories, an oncology and preventative care clinic, and educational and meeting spaces. Together, they create the perfect environment for EIT Oxford experts to take ground-breaking ideas from research to broad implementation. The new facility will further EIT’s current partnership with the University of Oxford and become the new home for Ellison Scholars.
EIT Oxford is committed to cultivating a community where excellence is achieved through collaboration, trust, innovation and tenacity. We foster an environment where everyone’s experience and expertise are valued. We are curious and resilient in our efforts to drive long-term, sustainable innovation to meet humanity’s most enduring challenges.
As the Head of Quality, you will play a pivotal role in shaping our quality strategy and overseeing its execution across all business areas, including our clinic and laboratory. This leadership position involves managing regulatory compliance, developing quality management systems (QMS), and driving continuous improvement initiatives while collaborating closely with the Clinic Manager and Laboratory Manager.
Key Responsibilities:
* Regulatory Compliance: Ensure all services and products meet applicable regulatory requirements (e.g., EU and GMP guidelines) and collaborate with regulatory bodies as needed.
* Quality Management Systems (QMS): Develop, implement, and maintain a QMS aligned with international standards (e.g., ISO 9001, ISO 13485) and customer expectations.
* Audits: Plan and conduct internal audits, oversee CAPA implementation, and prepare for external audits and inspections.
* Process Improvement: Lead initiatives to enhance quality, reduce waste, and improve operational efficiency.
* Supplier Quality Management: Ensure suppliers meet required quality standards and specifications.
* Root Cause Analysis: Investigate quality issues using tools such as 5 Whys and Fishbone diagrams, implementing effective resolutions.
* Risk Management: Identify and mitigate quality-related risks to safeguard operations and product integrity.
* Training & Development: Provide comprehensive training on quality standards, QMS, and best practices.
* Reporting: Deliver detailed quality performance reports and improvement strategies to senior leadership.
Essential Skills, Qualifications & Experience:
* Bachelor's degree in pharmaceutical or a science-related field.
* Minimum of 8-10 years in a quality management role.
* Qualified Person (QP).
* Strong knowledge of QMS and GMP regulations.
* Proven expertise in pharmaceutical or biotechnology quality practices.
* Outstanding leadership and team management skills.
* Ability to manage competing priorities in a dynamic environment.
* Meticulous attention to detail and commitment to excellence.
* Strong decision-making and interpersonal skills.
Desirable Skills, Qualifications & Experience:
* Experience in laboratories, cleanrooms, and pharmacy environments.
* Proficiency in quality tools such as FMEA, SPC, MSA, and CAPA.
* Knowledge of European and international pharmaceutical regulations, including familiarity with regulatory submissions.
We offer the following salary and benefits:
* Generous starting salary (negotiable depending on experience) + bonus + travel allowance
* Enhanced holiday pay
* Pension
* Life Assurance
* Income Protection
* Private Medical Insurance
* Hospital Cash Plan
* Therapy Services
* Perk Box
Why work for EIT:
At the Ellison Institute, we believe a collaborative, inclusive team is key to our success. We are building a supportive environment where creative risks are encouraged, and everyone feels heard. Valuing emotional intelligence, empathy, respect, and resilience, we encourage people to be curious and to have a shared commitment to excellence. Join us and make an impact!
Terms of Appointment:
* You must have the right to work permanently in the UK with a willingness to travel as necessary.
* You will live in, or within easy commuting distance of, Oxford.
* During peak periods, some longer hours may be required and some working across multiple time zones due to the global nature of the programme.
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