Director of Quality / QP

An exciting opportunity for an experienced Quality Leader to lead and strengthen the Quality function within a regulated sterile pharmaceutical manufacturing company.

You’ll drive Quality strategy, regulatory compliance, operational excellence, and continuous improvement, while building a strong quality culture across the site.

Key Responsibilities

• Lead, manage and develop the Quality organization for the site (100+ FTEs)
• Act as Qualified Person and oversee batch certification and release
• Act as Quality lead during FDA, EMA, and regulatory inspections
• Ownership and continuous improvement of the site's QMS
• Oversee QA, QC, validation, supplier quality, audits, CAPAs, deviations, and change control
• Ensure product release, inspection readiness, and regulatory compliance
• Develop and lead a high-performing Quality team
• Partner with senior leadership to support business growth and site strategy

Requirements

• 5+ years' Quality leadership experience in sterile pharmaceutical manufacturing
• Qualified Person for sterile pharmaceuticals
• Strong knowledge of GMP/cGMP, FDA, EMA, and ICH regulations
• Proven experience leading regulatory inspections and Quality Management Systems
• Degree in a Pharmacy ideally
• Strategic, collaborative leader with excellent stakeholder management skills
• Fluent English and French are necessary