Senior Director Quality Assurance & QP (m/f/d)

General responsibility for the planning, preparation, implementation and follow-up of self-inspections, customer audits and authority inspections (on-site, remote). This also includes ensuring a GMP-compliant response to all identified shortcomings; Monitoring of inspection-specific KPIs Main address for authorities in the processing of GMP requests in the course of authorisation procedures Coordination and processing of Q questions within customer planning overall responsibility for the Supplier Quality Management: qualification and monitoring of suppliers, service providers and contract laboratories based on risk-based approaches; planning and implementation of supplier audits (global, including USA/Asia); Head of the cross-departmental team responsible for evaluating Supplier Change Notifications; Creation and maintenance of quality agreements with suppliers, service providers and contract laboratories Responsible for the evaluation of materials used directly or indirectly in the process with regard to compliance with regulatory requirements and criticality for the production process or Patient safety Responsibility for Q release of raw materials and production materials for ordering within the SAP material master plant Monitoring of complaint management (SCAR process) including cross-departmental coordination with purchasing and specialist departments Leadership and further development of the team incl. Resource planning, KPI control and continuous process optimization Control of relevant interfaces to production, MSAT, QC, Regulatory Affairs, logistics, purchasing and business development/project management Ensuring compliance and further development of SOPs, quality processes and electronic QM systems Review of general and/or project-specific risk analyses on the regulatory requirements imposed on the process materials Release of active substance strains produced at the site for dispatch and further processing Quality Management Support for Preparing Superior Customer and Quality Board Meetings and Process Optimization Projects

Approbation as a pharmacist:in and specialist (Qualified Person according to §14 AMG / EU Directive) Multiannual professional experience in biopharmaceutical active substance production and approval (Drug Substance) Excellent knowledge of international pharmaceutical requirements and regulations such as AMG, AMWHV, EU-GMP, US CFR, ICH and FDA regulations Experience in the CDMO environment as well as in handling international customers Long-term professional experience and deep expertise in the relevant field Multiannual experience in the disciplinary leadership, motivation and development of employees and outstanding leadership qualities Experience in managing major projects German and English knowledge, in word and writing Very good knowledge of project management methods Impressed social competence and strong communication skills High level of entrepreneurial thinking and economic, strategic and solution-oriented thinking Identification with the company's internal leadership philosophy Outstanding collaborative capability with simultaneous enforcement capability Outstanding strategic capabilities to develop targeted strategies Ability to advance innovation, with good example, to give clear instructions for action Experience in the implementation of risk and problem management including risk identification strategies, tracking and mitigation strategies

Sensorship: Become part of a company that makes a real difference for seriously ill patients through the development and production of vital medicines Inspiring working atmosphere: Experience the joy of working in a collegial environment that promotes cooperation and team spirit on site Individual development opportunities: access to personalised training programmes Compensation: Attractive remuneration and annual performance (in the amount of a monthly salary) Flexible work design: flexible working hours, possibilities for mobile work, 30 holiday days and special holiday days Community breaks: Canteen with vegetarian/ vegan offer Health: Occupational health management, Occupational health, ECYM Wellpass Joint experiences: team and company events Environmentally friendly mobility: leasing offer for (e-)bikes, e-rollers and e-scooters Family-friendly support: In-house crèche Safe workplace: Future-proof industry with an unlimited contract Employee Benefits: Operational pensions, variety of staff rebates (Corporate Benefits), benefits from the job ticket, financial support for moving from a certain distance, free parking, comprehensive onboarding program