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(Senior) Manager Clinical Quality Assurance (m/f/d)

    Job description

    What awaits you:

    • Plan, conduct and report internal and external audits incl. communication of findings and recommendations to management and staff

    • Support the team in developing appropriate corrective and preventive actions, where appropriate

    • Perform risk management for projects and coordinate appropriate actions to assess and mitigate quality issues in collaboration with our project teams

    • Improving quality or resolving a GxP deficiency and monitoring the implementation of CAPA

    • Create, revise or review SOPs and quality related documents to ensure GxP Compliance and a risk-based approach to quality

    • Support Head of QA in implementing a risk-based GxP Quality Management, risk management and audit planning

    • Support the implementation and the maintenance of inspection readiness concepts and the preparation, hosting, and follow up of regulatory inspections

    • Be an integral part of interdisciplinary project teams as quality advisor

    • Organise and conduct quality related trainings to colleagues

    Job requirements

    What we look for in you:

    • You have a degree in natural sciences, medicine, quality management, or equivalent industry experience

    • Minimum of 5 years of experience in working for life sciences companies in a clinical quality management function,  preferably with  FiH / phase I studies experience in biotech or sponsor organization

    • In-depth knowledge of GCP regulatory requirements, knowledge in G(C)LP and GMP would be an advantage

    • Advocate of quality by design with a speak-up mentality

    • Ability to work in teams as well as in matrix organizations

    • Ability to see the big picture of early development, using analytical reasoning and strong problem solving skills to provide phase and risk proportionate guideance

    • Excellent communication skills in English and preferably in German

    What we offer:

    • Flexible working hours with compensation options and the opportunity to work remotely so that your job fits in with your life

    • Mentoring program: In addition to comprehensive onboarding, you will receive a buddy who will show you everything so that you feel at home quickly

    • Prospects for your personal and professional development: Benefit from our training program so that you can take your qualifications to a new level

    • We support you and your family through our “FamPlus” Employee Assistance Program, e.g. in organizing childcare or caring for relatives

    • We offer you a wide range of social benefits: Company pension scheme with employer subsidy, pension benefits as part of company health insurance and job bike

    • Would you like to improve your fitness? No problem, then join our weekly sports club

    • You can use our free charging stations for your electric car

    • Happy coffee break, weekly fruit day and regular great company events await you

    Would you like to work with us today on the medicine of tomorrow for the benefit of patients? Then become part of our team!

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