Senior EU QP - Cell Therapy QA & Compliance

Bristol Myers Squibb; Leiden; On-site; EUR 140,000 - 190,000; Full time

Job summary

Bristol Myers Squibb in the Netherlands is seeking a Manager QA, EU QP Cell Therapy to oversee the quality management system and act as Qualified Person for investigational and commercial ATMP products across Europe and Rest of World.

You will lead audits, release decisions, risk assessments, and continuous improvement of GMP/GDP processes while collaborating with global teams and external partners to ensure compliant, timely batch disposition.

Qualifications

• MSc in technical/scientific field and meets EU Qualified Person education requirements.
• Eligible to act as Qualified Person within EC/EEA; preferred.
• Extensive QA/QA experience in biotechnology (6+ years) including audits and investigations.
• Experience with aseptic manufacturing, biological products or cell therapy.
• Thorough knowledge of GMP/GDP requirements (EU).
• Excellent communication, interpersonal and negotiation skills.
• Strong organizational, project management and problem-solving abilities.

Responsibilities

• Act as Qualified Person per EU requirements for EU/EEA and Rest of World markets.
• Oversee and execute QA/QMS activities to ensure regulatory compliance for ATMP products.
• Perform release decisions and review non-routine quality investigations.
• Participate in GMP/GDP audits and implement corrective actions.
• Identify and implement product/process quality improvements.
• Maintain training compliance and manage quality agreements with contractors.

Education

MSc in technical or scientific discipline

Eligible to act as Qualified Person (EC/EEA)

Extensive QA/QC experience (6+ years in biotech)

Aseptic manufacturing knowledge

GMP/GDP regulatory knowledge (EU)

Strong communication skills

Organizational and project management

Problem solving and teamwork

Job description

Bristol Myers Squibb in the Netherlands is seeking a Manager QA, EU QP Cell Therapy to oversee the quality management system and act as Qualified Person for investigational and commercial ATMP products across Europe and Rest of World.

You will lead audits, release decisions, risk assessments, and continuous improvement of GMP/GDP processes while collaborating with global teams and external partners to ensure compliant, timely batch disposition.