Head of Quality Management International / Qualified Person according to § 14 AMG (m/f/d)

Overall responsibility for quality policy, quality objectives and the quality management system according to ISO 13485, FDA 21 CFR 820, MDR, GMP, AMG, AMWHV and other relevant Standards for the Neunkirchen sites at Brand, Glasgow and New Zealand Leadership and further development of Q-teams (QA, QM, QC) as well as securing an effective, site-wide cooperation Ensuring compliance for implants / tissue preparations, procedures and biomaterials including animal and human tissue Control of all QMS core processes (including risk management, CAPA, audits, process validation) and continuous improvement of the QMS system Central response for authorities and designated bodies in audits, inspections and certifications Monitoring of supplier quality and close inter-functional cooperation with relevant departments Development of quality indicators, implementation of management assessments and promotion of sustainable quality culture Mentoring and development of all employees in the area of responsibility Takeover of the tasks of the competent person (QP) according to § 14 AMG

Completed natural science or medical studies (e.g. chemistry, biochemistry, pharmacy, biology, human or veterinary medicine or engineering) or a comparable qualification Long-term experience in quality management for medical, pharmaceutical or pharmaceutical industries, ideally with international leadership Compensation for the acquisition of the ''expert person'' function according to § 14 AMG Very good knowledge of relevant laws, standards and regu­lationary requirements (including MDR, AMG, AMWHV) for medical devices, pharmaceuticals and tissue preparations Proven experience in leading international and international teams and in managing global quality systems Funded skills in change, risk and project management as well as in structured problem solving International readiness to travel (about 30%) Additional qualifications (e.g. ASQ, PMP) of advantage German and English skills

Sensual activity in an international, international company in the pharmaceutical and medical products sector Activities in a dynamic team with flat hierarchies Unlimited employment contract with attractive salary package 30 days holiday and generous home office scheme Ideal transport connection, both with public transport and with the car (company parking)