Site Quality Head - Leiden - Johnson & Johnson, Innovative Medicine

Biopharma Asia; Leiden; À distance; EUR 130 000 - 224 000; Plein temps

Avantages offerts par ce poste

Annual bonus with target

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson in Leiden seeks an experienced Senior Director Quality and Site Quality Head to lead the Quality organization across Janssen Biologics Leiden. You will oversee QA, QC and Quality Systems, ensuring the site meets the highest quality, regulatory and patient-safety standards.

You will be the senior Quality authority on site, shaping quality strategy, driving continuous improvement, and partnering with global teams to ensure inspection readiness and compliance.

Qualifications

• Advanced degree in a scientific or engineering discipline.
• 10–15 years of experience in a significant leadership role within the biologics and/or pharmaceutical industry.
• Minimum five years of experience in a senior Quality leadership position.
• Experience with FDA and EMEA regulatory requirements applicable to biologics and pharmaceuticals.
• Strong understanding of GMP regulations and global regulatory expectations.
• Proven success operating within a global organization.
• Experience in another key business function such as Manufacturing, Engineering, R&D, Technical Services or EHS is desirable.

Responsabilités

• Lead and develop the site Quality organization, including QA, QC and Quality Systems.
• Set the Quality strategy and ensure quality, compliance and business objectives are delivered.
• Provide strategic direction and leadership on quality systems, product release, compliance and inspection readiness.
• Serve as the senior Quality authority for the site, including product and material disposition, quality governance and product recall decisions.
• Build and maintain strong relationships with regulatory authorities, including the FDA, EMA/EU, IGJ, PIC/S and other applicable global health authorities.
• Monitor regulatory developments and advise site leadership on key quality risks, opportunities and regulatory expectations.
• Ensure regulatory filing requirements are effectively translated into site systems and procedures.
• Drive continuous improvement, operational excellence and Quality Performance Excellence initiatives.

Connaissances

Leadership

Strategic thinking

Quality management

Risk assessments

Stakeholder management

Formation

Advanced degree in a scientific or engineering discipline

Description du poste

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.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

Role summary

We are looking for an experienced Quality leader to join Johnson & Johnson Innovative Medicine as Senior Director Quality and Site Quality Head for our Leiden site.

As the most senior Quality leader on site, you will have overall responsibility for Quality and Compliance across Janssen Biologics Leiden. You will lead the Quality organization, including Quality Assurance, Quality Control and Quality Systems, ensuring the site operates to the highest standards of quality, regulatory compliance and patient safety.

This is a highly visible leadership role, combining strategic direction with operational oversight. You will be a member of the Site Leadership Team and a key member of the Global Quality Leadership Team, partnering across the organization to shape quality strategy, strengthen our quality culture and ensure continued inspection readiness and regulatory compliance.

Key responsibilities

Lead and develop the site Quality organization, including QA, QC and Quality Systems.

Set the Quality strategy and ensure quality, compliance and business objectives are delivered.

Provide strategic direction and leadership on quality systems, product release, compliance and inspection readiness.

Serve as the senior Quality authority for the site, including product and material disposition, quality governance and product recall decisions.

Build and maintain strong relationships with regulatory authorities, including the FDA, EMA/EU, IGJ, PIC/S and other applicable global health authorities.

Monitor regulatory developments and advise site leadership on key quality risks, opportunities and regulatory expectations.

Ensure regulatory filing requirements are effectively translated into site systems and procedures.

Drive continuous improvement, operational excellence and Quality Performance Excellence initiatives.

Develop operating and capital budgets for the Quality organization and contribute to COGS improvement initiatives.

Build a strong culture of quality, compliance, accountability and high performance.

Coach and develop Quality leaders and employees, building strong succession plans and talent pipelines.

Partner with Supply Chain Quality and global teams to harmonize quality policies, programs, guidelines and systems.

Sponsor cross-functional initiatives and collaborate effectively across functions, affiliates and global teams.

Ensure quality systems remain compliant, effective and inspection-ready.

Ensure compliance with company EHS policies, site safety requirements and applicable local regulations.

Travel as required to support business operations and quality activities.

Qualifications/Competencies

Education and experience

Advanced degree in a scientific or engineering discipline.

10–15 years of experience in a significant leadership role within the biologics and/or pharmaceutical industry.

Minimum five years of experience in a senior Quality leadership position.

Experience with FDA and EMEA regulatory requirements applicable to biologics and pharmaceuticals.

Strong understanding of GMP regulations and global regulatory expectations.

Proven success operating within a global organization.

Experience in another key business function such as Manufacturing, Engineering, R&D, Technical Services or EHS is desirable.

Leadership and functional capabilities

Strong strategic and enterprise mindset with the ability to translate strategy into results.

Demonstrated ability to lead, coach and develop high-performing teams.

Deep Quality management and compliance expertise.

Strong problem-solving, risk-management and continuous-improvement capabilities.

Ability to identify, communicate and effectively manage meaningful quality and compliance risks.

Strong stakeholder management, negotiation, presentation and relationship-building skills.

Ability to collaborate effectively across diverse teams, functions and cultures.

Strong business acumen and a results-oriented mindset.

Innovative, adaptable, resilient and passionate about Quality.

Demonstrated integrity and commitment to the highest standards of ethics, quality and compliance.

Location: Leiden, South Holland, Netherlands

Reports to: Vice President, Supply Chain Quality, BioTherapeutics

Required Skills:

Preferred Skills:

AI solution evaluation, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Strategic Thinking, Succession Planning, Tactical Thinking

The anticipated base pay range for this position is:

€129,800.00 - €224,480.00

Benefits:

In addition to base pay, we offer the following benefits*: 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. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Additional information:

The Netherlands: 8%.The annual base pay includes an 8% holiday allowance.

Het bruto jaarsalaris is inclusief vakantietoeslag van 8%.