Our client is a global biotech pioneer celebrated for its uniquely collaborative culture.
Run by entrepreneurs for entrepreneurs, they specialise in co-creating and scaling companies within their global ecosystem. They blend experienced drug discovery with agile operations to foster breakthroughs and deliver transformative medicines.
They are looking for an experienced IT Quality professional to join their friendly, fun and innovative IT team within the ecosystem of biotech companies on a 9 month fixed term contract basis.
The successful applicant will play a crucial role in ensuring high standards of data quality, security, and compliance across our client’s IT systems, especially those supporting scientific, clinical, and regulatory functions. The post holder will play a crucial role in delivering our client’s mission to improve standards by collaborating with internal teams, overseeing data quality processes, and upholding quality standards in IT systems used for research, clinical trials, and data management.
Key Responsibilities
Quality Management: Implement and maintain IT quality control processes to ensure compliance with GxP, 21 CFR Part 11, and other regulatory requirements in IT systems.
Data Quality Oversight: Regularly audit data quality for scientific and clinical trial data, identifying issues and collaborating with stakeholders to ensure high accuracy and reliability.
Compliance Support: Assist in ensuring data and systems align with regulatory compliance standards across clinical and preclinical data.
Project Support: Collaborate on IT and data projects to embed quality standards and ensure all deliverables meet compliance requirements.
Documentation and Reporting: Create and maintain quality documentation, including SOPs and policies, and report on data quality metrics and system compliance.
Continuous Improvement: Recommend and implement improvements to processes and systems that enhance data quality, security, and compliance.
Training and Support: Provide training to teams on IT quality standards and best practices in data management to support operational efficiency and regulatory readiness.
Skills & Experience
Education: Bachelor's degree or equivalent experience in Computer Science, Information Technology, Data Science, or a related field.
Experience: 3+ years in IT quality assurance, computer systems validation, data quality, or regulatory compliance, preferably within life sciences, pharmaceutical, or biotech industries.
Technical Skills: Proficiency in data management and quality tools, knowledge of GxP, Part 11 compliance, CSV according to GAMP principles, experience of ISO27001 and SOC frameworks would be an advantage.
Experience with IT systems such as AWS, Egnyte, DocuSign, or similar platforms.
Analytical Skills: Strong analytical and problem-solving abilities with attention to detail and data accuracy.
Communication Skills: Excellent verbal and written communication skills for effective collaboration with cross-functional teams.
Other Skills: Demonstrated ability to manage multiple priorities in a fast-paced environment and work independently or as part of a team.
This is a wonderful contract opportunity for an experienced IT quality professional to join a supportive, growing organisation in a highly influential role. Apply Now!
Location: Abingdon, England
Salary: £45000.00 - £55000.00 per annum + Benefits
