Qualified Person (QP) – Cell & Gene Technologies

Panda International; Geleen; On-site; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Opportunity to work in innovative biopharmaceutical environment

Exposure to advanced manufacturing technologies

Dynamic project-based contract

Job summary

A leading biotechnology firm in the Netherlands is seeking a Qualified Person (QP) to ensure compliance with GMP regulations within its Cell & Gene Technologies platform. The ideal candidate will oversee batch certification, manage quality investigations, and interact with regulatory authorities. This role offers the opportunity to work in an advanced biopharmaceutical setting and contribute to innovative therapies. Candidates with QP certification and background in GMP environments are encouraged to apply.

Qualifications

• Certified Qualified Person under EU regulations.
• Strong experience in GMP environments.
• Specialized knowledge in Cell & Gene Therapy is a plus.
• Experience with batch release, quality systems, and regulatory inspections.
• Strong understanding of quality investigations, deviations, and validation processes.
• Excellent communication and stakeholder management skills.

Responsibilities

• Certify batches in compliance with GMP guidelines.
• Approve product releases and manage recalls.
• Act as a liaison with regulatory authorities.
• Decide on the initiation of product recalls and manage recall activities when necessary.
• Act as the key contact person for discussions with regulatory authorities and third parties during recall situations.
• Assess and approve investigations related to non-conformities and out-of-specification (OOS) results.
• Review and approve validation activities.
• Ensure continuous regulatory compliance and stay up to date with evolving regulations and guidelines.
• Perform and support internal and external audits.
• Manage quality agreements for assigned projects.
• Maintain and develop QP technical knowledge through continuous professional development.

Skills

Qualified Person certification in accordance with EU GMP regulations

Experience in GMP-regulated pharmaceutical or biotechnology environments

Strong understanding of quality investigations

Excellent communication and stakeholder management skills

Job description

Qualified Person (QP) – Cell & Gene Technologies

Location: Geleen, Netherlands

Contract: 6-month contract (March 16, 2026 – September 15, 2026)

Platform: Cell & Gene Technologies

About the Role

We are seeking an experienced Qualified Person (QP) to support operations within an innovative Cell & Gene Technologies platform based in Geleen, Netherlands. In this role, you will play a key part in ensuring products are manufactured and released in compliance with GMP regulations, internal quality standards, and applicable regulatory requirements.

The Qualified Person is responsible for batch certification, oversight of quality investigations, and ensuring the highest standards of compliance and product quality in a highly regulated environment.

Key Responsibilities

• Release materials for GMP processing and certify that each batch has been produced in compliance with GMP guidelines, licenses, and specifications.
• Approve and sign the statement of approval and/or rejection for final products.
• Ensure that products comply with applicable clinical protocols and regulatory requirements.
• Decide on the initiation of product recalls and manage recall activities when necessary.
• Act as the key contact person for discussions with regulatory authorities and third parties during recall situations.
• Assess and approve investigations related to non-conformities and out-of-specification (OOS) results.
• Review and approve validation activities.
• Ensure continuous regulatory compliance and stay up to date with evolving regulations and guidelines.
• Perform and support internal and external audits.
• Manage quality agreements for assigned projects.
• Maintain and develop QP technical knowledge through continuous professional development.

Requirements

• Qualified Person certification in accordance with EU GMP regulations.
• Strong experience working within GMP-regulated pharmaceutical or biotechnology manufacturing environments.
• Knowledge of Cell & Gene Therapy or advanced therapy medicinal products (ATMPs) is highly desirable.
• Experience with batch release, quality systems, and regulatory inspections.
• Strong understanding of quality investigations, deviations, and validation processes.
• Excellent communication and stakeholder management skills.

What We Offer

• Opportunity to work within a cutting-edge Cell & Gene Technologies platform.
• A collaborative and highly regulated biopharmaceutical environment.
• Exposure to innovative therapies and advanced manufacturing technologies.
• A dynamic project-based contract in a leading biotech hub in the Netherlands.

Interested?

If you are an experienced Qualified Person looking for your next contract opportunity in the Netherlands, we would love to hear from you.

Apply now or reach out directly for more information.