Senior Director, Site Quality & Compliance

Biopharma Asia; Leiden; Remote; EUR 130,000 - 224,000; Full time

Benefits offered by this job

Annual bonus with target

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

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.

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.

Skills

Leadership

Strategic thinking

Quality management

Risk assessments

Stakeholder management

Education

Advanced degree in a scientific or engineering discipline

Job description

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.