Experienced Specialist QA (GMP)

Location: Leiden/Sassenheim, The Netherlands; hybrid work arrangement

Salary: €53,500–€85,445 annual base pay

Company

Johnson & Johnson MedTech develops healthcare and advanced therapy solutions designed to improve patient outcomes.

What you will do

• Provide QA oversight for Advanced Therapies commercial and clinical manufacturing operations.
• Guide GMP processes including change control, document control, training, deviation management, and inspection readiness.
• Support technology and analytical transfers, qualification and validation programs, aseptic processing, and Annex 1 compliance.
• Review investigations, non-conformances, CAPAs, risk assessments, and product disposition decisions.
• Represent Quality in facility, equipment, manufacturing, and capacity projects, including regulatory inspection preparation.
• Participate in a rotating 24/7 on-call schedule as the QA representative for quality-related issues.

Requirements

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific field.
• At least 6 years of experience in a GMP-regulated environment with a Bachelor’s degree, or 4 years with a Master’s degree.
• Experience in Quality Assurance, Quality Control, manufacturing operations, pharmaceuticals, or biotechnology.
• Strong knowledge of cGMP, ICH, FDA, EMA, change control, deviation management, CAPA, validation, and risk management.
• Understanding of manufacturing processes, laboratory operations, facilities, utilities, and technical automation systems.
• Fluent English and availability for the rotating 24/7 on-call schedule are required.

Nice to have

• Experience with Process Excellence, Co-Think, Kepner-Tregoe, or similar methodologies.
• Understanding of AI concepts, responsible and ethical AI practices, and effective prompting techniques.

Culture & Benefits

• Collaborative environment focused on learning, innovation, and professional development.
• Opportunity to contribute to Advanced Therapies manufacturing and products affecting patient care.
• Annual bonus with a target depending on pay grade and location.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health, plus eligible insurance plans.