Global Site Quality Head – Biologics Excellence

Leiden Bio Science Park; Leiden; On-site; EUR 140,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Service anniversary awards

Insurance plans

Holiday allowance

Job summary

Leiden Bio Science Park is seeking a senior Quality leader to dirige the site's Quality organization, including QA, QC and Quality Systems. You will set the Quality strategy, ensure compliance with GMP and global expectations, and provide strategic direction on product release and inspection readiness.

You will build relationships with regulatory authorities (FDA, EMA) and lead continuous improvement, risk management and governance initiatives across the site and global teams.

Qualifications

• Advanced degree in a scientific or engineering discipline.
• 10–15 years 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.
• 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.

Responsibilities

• Lead the site's Quality organization, including QA, QC and Quality Systems.
• Set the Quality strategy and ensure quality, compliance and business objectives are delivered.
• Provide strategic direction 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.

Skills

Quality leadership

Regulatory compliance

GMP/GxP

Regulatory affairs

Strategic thinking

People development

Cross-functional collaboration

Quality systems

Budgeting

Risk management

Education

Advanced degree in a scientific or engineering discipline

Job description

Leiden Bio Science Park is seeking a senior Quality leader to dirige the site's Quality organization, including QA, QC and Quality Systems. You will set the Quality strategy, ensure compliance with GMP and global expectations, and provide strategic direction on product release and inspection readiness.

You will build relationships with regulatory authorities (FDA, EMA) and lead continuous improvement, risk management and governance initiatives across the site and global teams.