Director, Quality Assurance — Biologics Leader

Johnson & Johnson; Leiden; On-site; EUR 101,000 - 175,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Job summary

Janssen Biologics (JBV), part of Johnson & Johnson, seeks a Director, Quality Assurance in Leiden, Netherlands. You will lead QA programs, ensure cGMP compliance, and oversee site inspections with Health Authorities.

Manage QA leadership and budgets to support manufacturing and release activities at the Leiden Biotherapeutics site. Advanced degree in science/engineering required with 10+ years in pharma QA; fluent English is essential, Dutch preferred.

Qualifications

• 10+ years of experience in a similar QA leadership role within pharma manufacturing of biologics or related products.
• Strong experience leading a large QA organization and managing regulatory inspections (FDA/EMEA).
• Fluent English; Dutch language skills preferred.

Responsibilities

• Lead all Quality Assurance programs and activities to support manufacturing, testing and release in full cGMP compliance.
• Serve as leader of the QA organisation, including performance goals and staff appraisals.
• Ensure inspection readiness and lead audits by Health Authorities, regulators, and customers.
• Establish and monitor metrics/targets for QA; manage operating and capital budgets to support quality objectives.
• Drive strategic direction for the QA groups and foster a culture of quality and regulatory compliance.

Skills

QA

Leadership

Regulatory

GMP

English

Dutch

Education

Advanced degree in science/engineering

Job description

Janssen Biologics (JBV), part of Johnson & Johnson, seeks a Director, Quality Assurance in Leiden, Netherlands. You will lead QA programs, ensure cGMP compliance, and oversee site inspections with Health Authorities.

Manage QA leadership and budgets to support manufacturing and release activities at the Leiden Biotherapeutics site. Advanced degree in science/engineering required with 10+ years in pharma QA; fluent English is essential, Dutch preferred.