Qualified Person

AssureBio; Manchester; On-site; GBP 70,000 - 100,000; Full time

Job summary

AssureBio is seeking an experienced Qualified Person (QP) to join their quality function in the UK. The role combines hands-on batch release with a leadership stake in the site's QMS.

This is an on-site, full-time role based in Manchester, offering scope to broaden responsibilities beyond release. You will review batch records and analytical data, lead investigations into deviations, support regulatory audits, and guide internal teams on quality standards while contributing to ongoing QMS

Qualifications

• A science degree in chemistry, pharmacy, biology or related field.
• Eligible QP (UK) status.
• Minimum 3 years' hands-on testing experience of active substances and medicinal products.
• QP release experience in sterile manufacturing, radiopharmaceutical or nuclear medicine is advantageous.
• Some experience managing a QMS or a Quality team.

Responsibilities

• Batch release of medicinal products with full regulatory compliance.
• Review and sign-off of batch records, analytical data and supporting documentation.
• Lead investigations into deviations and quality issues.
• Represent Quality at internal and regulatory audits.
• Advise internal teams on regulatory and quality standards.
• Contribute to ongoing QMS development and management.

Skills

QP release

QMS management

Regulatory compliance

Audits

Education

Science degree

Eligible QP (UK)

Job description

AssureBio is working with an established manufacturer in the radiopharmaceutical space to find an experienced Qualified Person (QP) to join their Quality function.

This role combines hands-on batch release with a leadership stake in the site's Quality Management System, ideal for a QP ready to broaden their scope beyond pure release.

What's involved:

• Batch release of medicinal products, ensuring full regulatory compliance
• Review and sign-off of batch records, analytical data and supporting documentation
• Leading investigations into deviations and quality issues
• Representing Quality at internal and regulatory audits
• Advising internal teams on regulatory and quality standards
• Contributing to ongoing QMS development and management

What you'll bring:

• A science degree (chemistry, pharmacy, biology or related)
• Eligible QP (UK)
• Minimum 3 years' hands-on experience in the quantitative/qualitative testing of active substances and medicinal products
• QP release experience within sterile manufacturing, radiopharmaceutical or nuclear medicine background strongly advantageous
• Some experience managing a QMS or a Quality team