QA Supervisor

Barrington James Limited; Greater Lincolnshire; Remote; GBP 55,000 - 75,000; Full time

Job summary

A leading biotechnology start-up in the UK seeks a QA Supervisor to enhance their quality management system while ensuring compliance with FDA and regulatory standards. The ideal candidate will have a scientific degree and over 4 years of experience in pharmaceuticals or biotech, with a preference for those with a background in sterile manufactured products. This role offers a remote working option, ideally suited for those in Central or Eastern Time Zones.

Qualifications

• 4+ years’ experience in pharmaceutical / CRO / Biotech.
• Experience in sterile manufactured products preferred.
• Exposure to Regulatory Affairs or an interest in learning the Regulatory Affairs role.

Responsibilities

• Develop/improve, implement, and maintain the quality management system (QMS).
• Oversee the evaluation and management of GxP suppliers.
• Collaborate with various departments for consistent quality.

Skills

Quality management systems

Regulatory compliance

Clinical quality risk management

Collaboration

Education

Bachelor’s degree in a scientific field

Job description

QA Supervisor | Full Time | Remote (ideally Central or Eastern Time Zones)

Innovative company whose aim is to brighten the future for those fighting cancer

Agile, tenacious, collaborative biotechnology start-up with a relentless focus on advancing real- time cancer imaging.

Responsibilities

• Develop/improve, implement, and maintain the quality management system (QMS) to comply with FDA, and regulatory
• Oversee the evaluation and management of suppliers to ensure the quality of products or services provided by GxP suppliers.
• Work with Clinical Operations to develop and implement clinical quality risk management strategies ensuring compliance with Good Clinical Practices (GCP).
• Collaborate with other departments, such as CMC, Clinical, Research and Development, and Regulatory Affairs, to ensure consistent quality across all aspects of the product lifecycle.

Qualifications & Skills

• Bachelor’s degree in a scientific field (e.g. Biochemistry / Biology / Chemistry).
• 4+ years’ experience in pharmaceutical / CRO / Biotech
• Experience in sterile manufactured products preferred
• Exposure to Regulatory Affairs or an interest in learning the Regulatory Affairs role is a plus.