Lead and continuously improve the GMP self-inspection program, including annual planning and execution Coach SMEs and audit teams to ensure strong inspection and self-inspection readiness Perform gap assessments on global procedures and drive alignment across site functions Coordinate cross-functional activities and ensure effective communication with all departments Support internal, external, and mock audit preparation, including document review and QA input Act as backroom/ACC or scribe team member during audits and inspections Serve as Data Integrity Champion and ensure consistent DI implementation across the site Prepare and present compliance topics to the Quality Council and site leadership Support continuous improvement initiatives and coordinate operational activities within the compliance team Act as back-up for the Quality Compliance & Systems Expert when required University degree in biochemistry, chemistry, engineering, or another relevant scientific/technical discipline Solid experience in biotechnology and/or pharmaceutical industry Strong knowledge of GMP requirements and Quality Systems Understanding of manufacturing, QC laboratory, and warehouse processes for biological products Solid knowledge of Good Documentation Practices (GDDP) and Data Integrity principles Experience supporting audits and regulatory inspections Skilled in writing, reviewing, and updating SOPs and technical documentation Familiarity with risk management tools (FMEA, RCA, etc.)
Background & experience • MSc or PhD in Chemical Engineering, Materials Science, Chemistry or a related field • 7+ years of experience in chemical and/or polymer manufacturing • Solid experience with solid propellants, energetic materials, composites and/or defence/aerospace materials (must have) • Proven track record in scale-up from lab to industrial production, including definition of process windows and critical parameters • Experience managing or leading an analytical laboratory and working closely with QC/QA • Familiarity with ISO / AQAP / defence quality systems and safety regulations for hazardous substances • Experience with SPC, root-cause analysis tools (5 Whys, Fishbone, FMEA) and data-driven process improvements • Working knowledge of MES/ERP systems and process data management is an advantage Personal competencies • High level of precision, accountability, and safety awareness – you do not compromise on quality or HSE • Clear, structured communicator who can translate complex chemistry and data into practical decisions for production teams and management • Strong people leadership skills – able to set direction, coach and develop specialists and technicians, and create engagement in a multicultural environment • Emotionally resilient and comfortable working in a fast-paced, scale-up setting with changing priorities • Curious, proactive, and solution-oriented, with a genuine interest in both technology and its real-world impact At FPRT, you will join at a pivotal moment, where you can directly influence how processes, standards and culture are shaped in Denmark.