Staburo GmbH is a data science company, specialized in statistical consulting, programming and bioinformatics for healthcare projects. Our core competencies include Clinical Statistics, Translational Medicine & Biomarkers, Phase I & Pharmacokinetics/-Dynamics, Data Transparency & Disclosure Services, Health Technology Assessment and Bioinformatics. Our customers are international pharmaceutical companies (7 of the top 20), CROs, biotech companies and medical device manufacturers. Our steadily growing team of 50 experts supports our clients efficiently from study design to data analysis and finally the disclosing and posting of trial results.
To expand our team in Munich, we are looking for a full- or part-time
Quality Assurance Manager (f/m/d)
Your responsibilities will include:
- You support the definition and implementation of the strategy and goals of Quality Assurance (QA) in the company, in accordance with applicable regulatory requirements (especially GCP).
- You plan, manage, and monitor of all QA activities.
- You are responsible for the life-cycle management of all QA documents. You coordinate the creation, review, and approval of all QA documents.
- You ensure compliance with training requirements and conduct internal trainings.
- You are responsible for the planning, implementation, and follow-up of internal and external audits.
- Completed degree with a focus on quality management, health sciences or comparable degree
- At least 2 years of professional experience in quality assurance of pharmaceutical companies or companies working in the strictly regulated area is an advantage
- Good ability to balance regulatory requirements, customer needs and company opportunities as well as the flexibility to adapt quickly to new requirements
- Excellent verbal skills and a high level of written accuracy
- Independent, precise, analytical, and solution-oriented approach to work
- Very good knowledge of MS Office products
- Very good English skills (all QA documents are written in English), German is an advantage
What we offer you:
We value communication, flat hierarchies, open corporate culture, and a harmonious work environment. We offer comprehensive individual development opportunities, continuous trainings, and flexible working hours. A modern and bright office, as well as the opportunity to work from home are part of our everyday working life. You will join an interdisciplinary team allowing you to discuss with and learn from peers with many different backgrounds.
Check our website: www.staburo.de and become part of our constantly growing team! Please send your complete application documents (incl. salary expectations) to: firstname.lastname@example.org. We look forward to meeting you soon!