Head of Quality Assurance, Quality Management Representative & Qualified Person (QP) (m/f/d)

Legally responsible batch certification according to EU-GMP and AMG Ensure that each batch has been manufactured and tested according to approval, GMP and specifications Ensuring compliance with all relevant legal and regulatory requirements (GMP, possibly GDP, AMG, AMWHV etc.) PQR creation Assessment and approval of deviations, CAPAs, OOS/OOT, Changes and customer complaints Creation & Testing of Quality Contracts Planning, implementation and follow-up of internal and external audits (authorities, designated bodies) Creation, testing and approval of SOPs and quality-relevant documents Responsibility for the GMP and ISO 13485-compliant training system Monitoring the effectiveness of the integrated QMS in particular of GMP, MDR and ISO 13485-compliant document steering Definition and use of KPIs for controlling and optimizing quality processes Implementation of the management review according to ISO 13485 Professional and disciplinary leadership and further development of the QS team Interdisciplinary cooperation with other national and international specialist departments Promoting a company-wide quality culture through cooperation in building a global quality system together with all the countries of the group of companies

Complete study of pharmacy Recognition as a qualified person (QP) according to AMG Funded knowledge in GMP and relevant regulations (AMG, AMWHV, ICH, etc.) Multiannual experience in pharmaceutical quality assurance Knowledge of MDR and ISO 13485 desirable Experience in dealing with authorities and designated bodies Experience in building, maintaining and developing QM systems Embossed leadership and communication strength High responsiveness and determination Analytical thinking and structured working Ability to understand complex regulatory requirements Very good understanding of complex processes and relationships Structured, solution-oriented operation Communication strength and ability to mediate between different stakeholders Very good English skills in word and writing

An exciting and varied activity to develop your professional and personal perspectives An international environment with teams and stakeholders from different countries and cultures A competent, motivated and sympathetic team An attractive salary, company pensions and other corporate benefits (Job-Rad, Wellpass, company discounts etc.) Slide-time work model with up to 40% Smart-Working share