Director Quality Assurance (Biologics)

Location: Leiden, South Holland, Netherlands

Salary: €101,000–€174,800 per year

Company

Johnson & Johnson MedTech develops healthcare, innovative medicine, and biotherapeutic solutions designed to prevent, treat, and cure complex diseases.

What you will do

• Lead quality assurance, compliance, testing, and product release programs supporting clinical and commercial biotherapeutics manufacturing.
• Ensure products are manufactured and released in compliance with cGMP, company policies, and governmental quality and regulatory requirements.
• Lead the site QA organization, including performance goals, employee appraisals, mentoring, coaching, and professional development.
• Maintain inspection readiness and lead health authority, regulatory compliance, and customer audits.
• Set and monitor quality metrics and targets while managing operating and capital expense budgets.
• Provide strategic direction to quality groups and promote a collaborative culture of quality and compliance across the site.

Requirements

• Advanced degree or equivalent experience in a scientific or engineering field.
• At least 10 years of experience in a similar position within pharmaceutical manufacturing of biotherapeutic products.
• Strong experience leading large teams in complex organizations.
• Knowledge of FDA and EMEA regulatory requirements for biologics or pharmaceuticals, with the ability to apply GMP and international guidelines.
• Fluent English is required; Dutch knowledge is preferred.
• Demonstrated success leading within a global organization.

Nice to have

• Experience holding a Qualified Person role under a site manufacturing license.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and employee development.
• Annual performance bonus based on pay grade, location, and employee and company performance.
• Vacation, 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.
• Service anniversary and recognition awards, plus eligibility for several insurance plans subject to plan terms.