Head of Quality Assurance / GCP - GVP (m/f/d)

Your duties Strategic leadership: developing and implementing comprehensive QA strategies that match the organisational objectives and regulatory requirements. Establishing and maintaining robust quality management systems (QMS) to support clinical trials and pharmacovigilance activities. Regulatory Compliance: Ensure that all clinical trials and pharmacovigilance activities comply with global regulations, including ICH GCP and EMA guidelines. Audit and inspection management: monitoring internal and external audits and regulatory inspections to ensure compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP). Leadership and development of the team: leadership and mentoring of a team of quality assurance managers and promotion of quality culture as well as continuous improvement processes. Risk management: identifying potential quality risks in clinical trial and PV processes and developing appropriate mitigation strategies. Monitoring the investigation and elimination of quality problems, deviations and non-conformities related to GCP and GVP and ensuring the timely implementation of corrective and preventive measures. Monitoring the quality system: implementation and maintenance of comprehensive quality assurance and control systems, including standard work instructions (SOPs), to ensure compliance with written procedures, business processes, regulatory requirements and quality standards for GCP and GVP. Ensure that all activities in clinical trials and pharmacovigilance are carried out in accordance with established quality systems and applicable GCP and GVP regulations. Collaboration and Communication: Cooperation with cross-functional teams to integrate quality standards and communication of quality indicators, audit results and compliance status to senior management and other stakeholders.

Your qualification Graduate in Medicine, Pharmacy or Natural Sciences Professional experience in the pharmaceutical industry in quality assurance for clinical research and/or pharmacovigilance Comprehensive expertise of GCP, GVP requirements Ideally experience as GCP or GVP editor Embossed process thinking Very good knowledge of German and English in word and writing

Your advantages New Work, Mobile Work and Flexible Working Hours Various benefits such as Hansefit, Jobrad, Germanyticket, kindergarten grant and purchase of additional holiday days Comprehensive onboarding and mentoring program Individual training opportunities International and growing family business with short decision-making and financial independence For questions, Julia Odebrecht is available via e-mail at personal@drfalkpharma.de or under the telephone number 0761 1514 5513. We look forward to your application via our online portal.