Director of Quality

Darum lohnt es sich

Key Responsibilities • Build and lead the Quality, Regulatory Affairs, and Compliance function from the ground up. • Develop and implement robust GMP quality systems, policies, and procedures. • Lead site quality strategy, regulatory compliance, and inspection readiness activities. • Support facility licensing, validation, qualification, and operational readiness programmes. • Act as the primary quality and regulatory representative with customers and health authorities. • Lead regulatory inspections, customer audits, and internal audit programmes. • Establish a culture of quality, compliance, and continuous improvement across the organisation. • Partner closely with Manufacturing, Technical Operations, Engineering, Supply Chain, and Executive Leadership teams. • Support the transition from project phase through to commercial manufacturing operations.

Candidate Profile The successful candidate will bring: • 15+ years of experience within Quality, Regulatory Affairs, or Compliance in pharmaceutical, biotechnology, or CDMO environments. • Significant experience within sterile manufacturing environments. • Deep expertise in aseptic processing, injectables, biologics, and GMP compliance. • Proven experience supporting greenfield projects, site start-ups, facility licensing, or major manufacturing expansions. • Strong experience managing regulatory inspections, health authority interactions, and audit readiness programmes. • Demonstrated success building quality systems, compliance frameworks, and quality organisations from the ground up. • Strong leadership, stakeholder management, and communication skills. • Experience engaging with executive leadership teams, investors, customers, and regulatory authorities.

Vice President Quality, Regulatory Affairs & Compliance Location: Germany The Vice President Quality, Regulatory Affairs & Compliance will be responsible for building and leading the Quality, Regulatory Affairs, and Compliance function for a new sterile manufacturing facility, playing a critical role in site start-up, regulatory approvals, operational readiness, and long-term commercial success.

Working closely with executive leadership, investors, customers, and regulatory authorities, the successful candidate will help shape one of Europe's future sterile manufacturing platforms.

Preferred Experience • Qualified Person (QP) certification highly desirable. • Experience working with EMA, FDA, MHRA, and other major regulatory authorities. • Previous experience within high-growth pharmaceutical, biotech, or CDMO organisations. • Experience supporting facility design, commissioning, qualification, and validation activities. • Shape the quality and regulatory strategy of a next‑generation sterile manufacturing facility. • Significant influence across site development, regulatory approvals, and operational readiness. • High visibility with executive leadership, investors, and strategic customers. • Opportunity to help build one of Europe's future sterile manufacturing platforms.