Director of Quality – Founding Leadership Role

About the role

Join a founding leadership team to build and lead the Quality, Regulatory Affairs and Compliance function for a next‑generation sterile pharmaceutical manufacturing facility in Portugal. This senior position offers direct exposure to executive leadership, investors, customers and global health authorities.

Key responsibilities

• Define and implement quality systems, GMP compliance and regulatory strategies for sterile manufacturing.
• Lead regulatory submissions, inspections and audit‑readiness programs with EMA, FDA, MHRA and other authorities.
• Support greenfield projects, site start‑ups, facility licensing and major expansions.
• Manage cross‑functional teams and ensure alignment with business objectives.
• Represent the organization in interactions with health authorities, investors and customers.

Required profile

• 15+ years of experience in Quality, Regulatory Affairs or Compliance within pharma, biotech or CDMO environments.
• Deep expertise in sterile manufacturing, aseptic processing, injectables and biologics.
• Proven track record in greenfield projects, site start‑ups and regulatory inspections.
• Strong leadership and communication skills.
• QP certification and experience with EMA, FDA or MHRA highly desirable.

Required skills

• Sterile manufacturing
• Aseptic processing
• GMP compliance
• Regulatory affairs (EMA, FDA, MHRA)
• Quality systems development
• Audit readiness
• Site licensing
• Greenfield project management
• Biologics
• Injectables

What we offer

• Founding leadership position with high impact.
• Direct interaction with executive leadership and investors.
• Opportunity to shape Europe’s future sterile manufacturing platform.
• Relocation package.