Senior Site Quality Leader – Leiden | Global GMP

Johnson & Johnson Co.; Amsterdam; On-site; EUR 130,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave (12 weeks)

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine in Leiden seeks a Senior Director of Quality and Site Quality Head to lead the Leiden Quality organization, including QA, QC and Quality Systems.

You will drive the site quality strategy, ensure regulatory compliance and patient safety, and partner across global teams to shape quality culture and inspection readiness. This is a high-visibility role reporting to the VP, Supply Chain Quality, BioTherapeutics.

Qualifications

• Advanced degree in a scientific or engineering discipline.
• 10–15 years in a significant leadership role within biologics/pharma.
• Minimum five years in a senior Quality leadership position.
• Experience with FDA/EMEA regulatory requirements for biologics/pharma.
• Strong GMP knowledge and global regulatory expectations.
• Experience in a global organization is preferred.

Responsibilities

• Lead and develop the on-site Quality organization (QA, QC, QMS).
• Set and deliver the site Quality strategy to meet compliance and business goals.
• Provide direction on quality systems, product release, compliance, and inspection readiness.
• Serve as the senior Quality authority for the Leiden site and govern product/material disposition.
• Build relationships with regulators (FDA, EMA/EU, IGJ, PIC/S) and health authorities.
• Monitor regulatory developments and advise leadership on risks and opportunities.
• Translate regulatory filing requirements into site procedures.
• Drive continuous improvement and Quality Performance Excellence initiatives.
• Develop budgets for Quality and contribute to COGS improvement.
• Foster a culture of quality, accountability, and high performance.
• Coach and develop Quality leaders and succession plans.
• Collaborate with Supply Chain Quality and global teams to harmonize policies.
• Sponsor cross-functional initiatives and ensure inspection readiness.

Skills

Quality governance

Regulatory compliance

People leadership

GMP experience

Stakeholder management

Strategic thinking

Risk management

Cross-functional collaboration

Education

Advanced degree in science or engineering

Job description

Johnson & Johnson Innovative Medicine in Leiden seeks a Senior Director of Quality and Site Quality Head to lead the Leiden Quality organization, including QA, QC and Quality Systems.

You will drive the site quality strategy, ensure regulatory compliance and patient safety, and partner across global teams to shape quality culture and inspection readiness. This is a high-visibility role reporting to the VP, Supply Chain Quality, BioTherapeutics.