Associate Specialist Quality Assurance (GMP)

Location: Leiden, Netherlands

Salary: €38,300–€61,410 per year

Company

Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions, including innovative medicines and medical technologies.

What you will do

• Ensure GMP compliance during product introduction and lifecycle management in the manufacturing environment.
• Review electronic batch records, support batch disposition, and prepare release packages for Qualified Persons.
• Review and release raw materials while maintaining accurate material master data in quality systems.
• Assess, approve, and verify change controls and review GMP documentation, including master batch records, validation reviews, and shipment documentation.
• Support local and global quality projects, process optimization, and a strong quality culture.

Requirements

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or a related scientific discipline.
• At least two years of experience in a GMP-regulated environment within Quality Assurance, Quality Control, Manufacturing, pharmaceutical, or biotechnology functions.
• Strong knowledge of GMP regulations, quality systems, batch release, change control, and compliance requirements.
• Experience in the biotechnology or pharmaceutical industry; knowledge of gene therapy and biological products is advantageous.
• Strong analytical, problem-solving, decision-making, communication, influencing, and stakeholder management skills, with close attention to detail.
• Excellent written and verbal English is required. Dutch language skills are a plus.

Culture & Benefits

• Inclusive work environment focused on respect, diversity, and employee dignity.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Annual bonus, service anniversary and recognition awards, and eligible insurance plans subject to applicable terms.

Hiring process

• Application and CV review.
• Short recruitment call for suitable candidates.
• Country-specific checks before starting the role, followed by a candidate feedback survey.