Experienced cGMP Specialist for Facility Management – experienced within Audit Readiness, Regulatory Requirements, and Audits

Job description

We seek an experienced cGMP Specialist to lead audit readiness for Facility Management. You will act as the Subject Matter Expert for Facility Management compliance, ensuring sustained inspection readiness, robust documentation, and effective CAPA management across cleanrooms, cleaning/disinfection, gowning, pest control, maintenance and supplier oversight. The role includes close collaboration with QA, Production, Regulatory, EHS, and external partners, and active participation in customer and authority inspections. The role: The Facility Management Compliance Group holds compliance responsibility for building maintenance, cleaning, gowning inventory, and pest control, as well as compliance support for strategic Facility projects. In close collaboration with internal stakeholders (Facility Contract Management, QA, Production, EHS, Regulatory) and external service partners, you will ensure that the Facility Management Compliance function is always inspection-ready without compromising daily operations. You will act as the cGMP SME for Facility Management, lead our audit readiness program, actively participate in customer audits and regulatory inspections (e.g., Danish Medicines Age...