Pharmacist (m/f/d) (Pharmacist)

Introduction

At Daiichi Sankyo, we stand united behind a single goal: to improve lives around the world through innovative medicines. With active innovation since 1899, a presence in more than 30 countries, and over 19,000 employees, we develop groundbreaking therapies in oncology, cardiovascular diseases, rare diseases, and immunological diseases. In alignment with our Vision 2030, "to be an innovative global healthcare company that contributes to the sustainable development of society," we are shaping a healthier, more hopeful future for patients, their families, and society.

To strengthen our team, we are looking for an experienced and committed leader for our location in Pfaffenhofen as

Head of Qualified Person (m/f/d) Regional Quality

As Head of Qualified Persons, you will take on a central role in ensuring the quality and regulatory compliance of our medicinal products and clinical trial medicinal products in Europe. You will bear overall responsibility for the QP function in the regional environment and lead a team of experienced Qualified Persons.

• Responsibility for the QP release of commercial medicinal products and clinical trial medicinal products in accordance with AMG, AMWHV, as well as EU-GMP (Annex 13 & 16)
• Ensuring GMP- and marketing authorization-compliant manufacturing, testing, and supply chain
• Leadership and further development of a team of Qualified Persons (QP)
• Decision-making regarding the release or rejection of batches, materials, and products
• Responsibility for supplier qualification, including auditing of CMOs, CROs, and testing laboratories
• Management 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
• Point of contact for authorities and inspections at a senior level
• Further development and optimization of release processes and quality systems

Professional Requirements:

• License as a pharmacist (Approbation) and expert knowledge in accordance with §15 AMG
• Qualification as a Sachkundige Person (§14 AMG) is mandatory
• Several years of experience as a Qualified Person with a focus on QP release decisions and coordination
• Experience in the release of investigational medicinal products (IMP)
• Sound knowledge of EU-GMP regulations as well as clinical requirements (CTR, Annex 13 & 16)
• Practical experience in sterile biotechnological manufacturing
• Extensive experience in process management as well as in the implementation of quality improvements
• Proven ability to manage and coordinate interdisciplinary projects
• Experience in dealing with inspections and authorities
• Business fluent English

Personal Competencies:

• Several years of leadership experience, ideally in leading QP teams or comparable functions
• Clear, structured, and transparent communication at all management levels
• Strong decision-making skills and sense of responsibility
• High social competence as well as the ability to effectively involve different stakeholders
• Structured, solution-oriented, and independent way of working

Attractive Benefits

• Work-Life-Balance
• Personal growth and development
• Health and well-being