Director, Quality Assurance — Biologics Lead

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

Benefits offered by this job

Annual bonus

Vacation days

Well-being programs

Job summary

Johnson & Johnson is recruiting a Director, Quality Assurance in Leiden, the Netherlands. The role leads all QA programs, ensuring products are manufactured and released in strict accordance with cGMP and regulatory standards.

The position manages the QA organization, drives performance goals, and ensures inspection readiness while collaborating with global regulatory authorities to maintain compliance.

Qualifications

• At least 10 years’ experience in a similar position within the pharmaceutical industry manufacturing biotherapeutics products.
• Strong experience in leading large teams in a complex organization.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals and ability to apply GMP regulations; proven global leadership.
• Fluent English; Dutch knowledge preferred.

Responsibilities

• Lead all QA programs and activities to support manufacturing, testing and release in full cGMP compliance.
• Head the QA organisation in technical and personnel aspects, with performance goals and appraisals.
• Ensure inspection readiness and lead Health Authority/regulatory/audit processes.
• Establish and meet quality metrics/targets and contribute to cost optimization.
• Provide strategic direction to quality groups and foster a culture of quality and compliance.

Skills

QA Leadership

Quality Assurance

GMP Knowledge

Education

Advanced degree in scientific or engineering field

Job description

Johnson & Johnson is recruiting a Director, Quality Assurance in Leiden, the Netherlands. The role leads all QA programs, ensuring products are manufactured and released in strict accordance with cGMP and regulatory standards.

The position manages the QA organization, drives performance goals, and ensures inspection readiness while collaborating with global regulatory authorities to maintain compliance.