Director of Quality

About the role

The Director of Quality will build and lead the Quality, Regulatory Affairs, and Compliance function for a new sterile manufacturing facility in Germany. Reporting to executive leadership, the role is pivotal for site start‑up, regulatory approvals, and long‑term commercial success.

Key responsibilities

• Establish and manage the Quality, Regulatory Affairs, and Compliance organization from scratch.
• Design, implement and maintain GMP quality systems, policies and procedures.
• Lead site quality strategy, regulatory compliance and inspection readiness.
• Support licensing, validation, qualification and operational readiness programmes.
• Act as primary quality and regulatory liaison with customers and health authorities.
• Lead regulatory inspections, customer audits and internal audit programmes.
• Promote a culture of quality, compliance and continuous improvement across the site.
• Collaborate closely with Manufacturing, Technical Operations, Engineering, Supply Chain and Executive Leadership.
• Guide the transition from project phase to commercial manufacturing operations.

Required profile

• 15+ years of experience in Quality, Regulatory Affairs or Compliance within pharmaceutical, biotechnology or CDMO environments.
• Extensive experience in sterile manufacturing, aseptic processing, injectables and biologics.
• Proven track record supporting greenfield projects, site start‑ups, facility licensing or major expansions.
• Strong background managing regulatory inspections, health‑authority interactions and audit readiness.
• Demonstrated ability to build quality systems and compliance frameworks from the ground up.
• Excellent leadership, stakeholder management and communication skills.
• Experience engaging with executive leadership, investors, customers and regulators.
• Qualified Person (QP) certification is highly desirable.

Required skills

• Aseptic processing
• Injectables manufacturing
• Biologics production
• GMP compliance
• Regulatory inspections
• Audit readiness programmes
• Facility licensing
• Validation and qualification activities
• Interaction with EMA, FDA, MHRA and other major regulatory authorities