As a medium-sized company based in Ladenburg near Heidelberg, we attach great importance to an open and collegial working atmosphere. We are on first-name terms, enjoy working in a team and take responsibility for our work area.

Together we are working on a new treatment approach in oncology. Based on our ADC technologies, we are developing novel drugs for the targeted and highly effective treatment of cancer. ADCs are antibody drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. We use several compounds and have built up an ADC toolbox that overcomes tumor resistance via numerous pathways and addresses different types of cancer using various antibodies. Our goal is to develop targeted and highly effective ADCs for the treatment of a variety of malignant hematologic and solid tumors.

We offer varied positions in research, development and administration. We accompany you on your personal career path and offer you a variety of opportunities to develop yourself further.

Curious? Then apply today and become part of our team!

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

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

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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Heidelberg Pharma AG

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