Director Quality Assurance

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 101,000 - 175,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health insurance

Job summary

Janssen Biologics, part of Johnson & Johnson, seeks a Director of Quality Assurance in Leiden to oversee QA programs for manufacturing, testing and release of biotherapeutics. You will lead the QA organization, align with cGMP standards, and ensure readiness for inspections by authorities such as FDA/EMEA.

The role requires a strong track record in large-team leadership within pharma, fluent English, and ideally Dutch. Includes challenging regulatory interfaces and cross-functional collaboration.

Qualifications

• 10+ years in a pharmaceutical manufacturing/biotherapeutics position.
• Experience leading large teams and managing regulatory inspections.

Responsibilities

• Lead QA programs for manufacturing, testing and product release in line with cGMP and regulatory guidelines.
• Direct QA organisation, set performance goals and conduct appraisals; ensure inspection readiness.
• Engage with local/regional/national regulators, and drive budgeted quality improvements.

Skills

Quality Assurance (QA)

Leadership

GMP

Quality Standards

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

All Job Posting Locations: Leiden, South Holland, Netherlands

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

People Leader

Job Description

Janssen Biologics (JBV) is recruiting for a Director, Quality Assurance, reporting to the Site Quality Head Leiden Biotherapeutics and located in Leiden, the Netherlands. This position is responsible for leading all Quality Assurance related programs and activities to support the JBV site. These functions and activities include Quality Assurance and product release activities. Ensures that products align with applicable standards and have been manufactured and released according to cGMP.

Key Responsibilities

Leads and handles all Quality & Compliance related programs supporting manufacturing, testing and release. This includes the clinical and commercial manufacturing and testing in full compliance with all J&J and governmental environmental, health, safety, quality and regulatory policies and guidelines. Leader of QA organisation in technical and personnel aspects, definition of performance goals and employee’s appraisals. Ensure inspection readiness and lead Health Authority, regulatory compliance, and customer audits. Assures that appropriate metrics/targets are established and met. Ensures financial leadership by developing appropriate operating and capital expense budgets and strives to have the Quality organization contribute to COGS improvement. Provide leadership to direct reports through: Developing and championing an organizational culture that promotes behaviours that lead to outstanding business performance and organizational excellence. Engages in proactive relationships with the local/regional/national regulatory authority. Encourages, supports, and advises initiatives and programs that lead to improved quality and regulatory compliance. Leads and guides staff and those involved in quality activities to achieve the best results. Mentors and coaches’ staff, as well as develops and implements training programs, to ensure professional and personal development of department personnel.

Experience and Skills Required

• At least 10 years’ experience in a similar position within the pharmaceutical industry manufacturing biotherapeutics products
• Strong experience in leading a large team in a complex organization, daily, but also through regulatory inspections (e.g. FDA, EMEA etc.).
• Knowledge of, and experience with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals is a must.
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Shoun success in leading in a global organization
• Fluent knowledge of English language.
• Dutch knowledge is highly preferred.

Preferred

• Experience on a site manufacturing licence as Qualified Person

Required Skills

• Quality Assurance (QA)

Preferred Skills

• Good Manufacturing Practices (GMP)
• Leadership
• Quality Standards

Salary

The anticipated base pay range for this position is: €101 000,00 - €174 800,00

Benefits

• In addition to base pay, we offer an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Vacation days.
• Parental leave for a minimum of 12 weeks.
• Bereavement leave.
• Caregiver leave.
• Volunteer leave.
• Well‑being reimbursement.
• Programs for financial, physical and mental health.
• Service anniversary and recognition awards.
• Employees, and in some location’s eligible dependents, can participate in several insurance plans, subject to the terms of their respective plans.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.