Daiichi Sankyo Europe GmbH | Germany | 85xxx Pfaffenhofen an der Ilm | Permanent position | Full time | Published since: 16.10.2026 on stepstone.de
Head of Qualified Person Regional Quality (m/f/d)
At Daiichi Sankyo we are united behind a single goal: to improve life around the world through innovative medicines. With active innovation since 1899, presence in more than 30 countries and over 19,000 employees, we develop groundbreaking therapies in oncology, cardiovascular diseases, rare diseases and immune diseases. In line with our vision 2030, "to be an innovative global healthcare company that contributes to the sustainable development of society," we create a healthier, hopeful future for patients, their families and society. To strengthen our team, we are looking for an experienced and committed leadership personality for our location in Pfaffenhofen as Head of Qualified Persons (m/w/d) As Head Qualified Persons, you play a central role in ensuring the quality and regulatory compliance of our medicines and clinical trials in Europe. They bear the overall responsibility for the QP function in the regional environment and lead a team of experienced qualified persons. .
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Your tasks • Your profile • What we offer
Responsibility for QP release of commercial medicines and clinical trials according to AMG, AMWHV and EU-GMP (Annex 13 & 16) Ensuring GMP and approval-compliant production, testing and supply chain Leadership and development of a team of Qualified Persons (QP) Decision on the release or rejection of batches, materials and products Responsibility for supplier qualification, including auditing of CMOs, CROs and test laboratories Control and Evaluation of Quality Events (Deviations, Changes, Complaints, PQR/APR) Creation and approval of regulatory documents (e.g. QP-Declarations, IMPD, CMC documentation) Interface management with internal functions (e.g. QA, Regulatory, Supply Chain) and external partners Contact for authorities and inspections at senior level Further development and optimization of release processes and quality systems
Approbation as a pharmacist and expertise according to §15 AMG Qualification as a specialist (§14 AMG) mandatory Multiannual experience as a qualified person with a focus on QP release decisions and votes Experience in the release of clinical trials (IMP) Knowledge of EU GMP regulations and clinical requirements (CTR, Annex 13 & 16) Practical experience in sterile biotechnological production Extensive experience in process management and implementation of quality improvements Detectional ability to control and coordinate interdisciplinary projects Experience in dealing with inspections and authorities Negotiating English Personal competencies: Multiannual leadership experience, ideally managed by QP teams or comparable functions Clear, structured and transparent communication at all management levels Impressed decision strength and sense of responsibility High social competence and ability to effectively integrate different stakeholders Structured, solution-oriented and independent mode of operation
Attractive Benefits Work-life balance Personal growth and development Health and well-being
Location
 | Daiichi Sankyo Europe GmbH | |
| 85276 Pfaffenhofen an der Ilm | ||
| Germany |
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