Senior Quality Systems Lead – GMP & CSV

OXB; Oxford; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading biopharmaceutical firm in Oxford is seeking a Senior Quality Systems Officer to manage Quality Management Systems (QMS) and oversee documentation related to computer systems validation. Candidates should possess A-Level education in science or equivalent, along with significant experience in the biopharmaceutical industry. The role involves driving projects for quality improvements, managing supplier qualifications, and ensuring regulatory compliance for ongoing operations. The company values collaboration, inclusivity, and offers numerous wellbeing programmes.

Benefits

Wellbeing programmes

Career development opportunities

Supportive and inclusive culture

State-of-the-art labs and manufacturing facilities

Qualifications

• Significant experience in Quality Management Systems within the biopharmaceutical/pharmaceutical industry.
• Proven background in Pharmaceutical QA, including audits, inspections, investigations, root cause analysis, and change control.
• Experience managing electronic Quality Management Systems and document/records management in a regulated environment.

Responsibilities

• Maintain Quality Management Systems (QMS) including CSV documentation.
• Lead improvements to the QMS, driving projects and compliance monitoring.
• Manage supplier qualification and maintenance.

Skills

Quality Management Systems

GMP and regulatory standards

Data integrity

Continuous improvements

Microsoft Office (Word, Excel, Outlook, PowerPoint)

Education

A-Level education in science or equivalent

Job description

A leading biopharmaceutical firm in Oxford is seeking a Senior Quality Systems Officer to manage Quality Management Systems (QMS) and oversee documentation related to computer systems validation. Candidates should possess A-Level education in science or equivalent, along with significant experience in the biopharmaceutical industry. The role involves driving projects for quality improvements, managing supplier qualifications, and ensuring regulatory compliance for ongoing operations. The company values collaboration, inclusivity, and offers numerous wellbeing programmes.