Lead Qualified Person – UK, Batch Release & Compliance

Moderna Therapeutics; Oxford; On-site; GBP 60,000 - GBP 80,000; Full time

Job summary

A pioneering biotechnology firm in the UK is looking for a Qualified Person to ensure the release of mRNA-based drug products comply with regulatory standards. The role involves certifying batch releases, overseeing quality systems, and participating in audits. Candidates must have a Life Science degree and minimum 10 years of experience in quality roles. This position offers competitive salary and comprehensive benefits focusing on well-being and professional development.

Benefits

Best-in-class healthcare

Generous paid time off

Family building benefits

Qualifications

• Minimum of 10 years' experience in quality roles within biotechnology/pharmaceutical industry.
• Eligibility to act as a Qualified Person with demonstrable knowledge of biologics.
• Experience in GMP-regulated pharmaceutical environments.

Responsibilities

• Certifying and authorising batch releases in compliance with regulations.
• Overseeing Quality management systems and ensuring compliance.
• Participating in regulatory inspections and audits.

Skills

Knowledge of biologics and sterile manufacturing

Expertise in Pharmaceutical Quality Management Systems

Strong communication skills

Agile and innovative mindset

Education

Life Science degree

Postgraduate qualification

Tools

Quality Risk Management (QRM) tools

Job description

A pioneering biotechnology firm in the UK is looking for a Qualified Person to ensure the release of mRNA-based drug products comply with regulatory standards. The role involves certifying batch releases, overseeing quality systems, and participating in audits. Candidates must have a Life Science degree and minimum 10 years of experience in quality roles. This position offers competitive salary and comprehensive benefits focusing on well-being and professional development.