At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
The Position:
The Team Lead GMP/GDP QA Affiliate Management will be responsible for managing a team ("country cluster") of local Quality Managers/Responsible Persons and Quality Experts located in DSE/DSE EU Affiliates.
Roles and Responsibilities:
- Lead a multinational team of approx. 5–7 Senior Quality Managers, Quality Experts, and externals in EU Affiliates
- Plan, coordinate, and manage operational QA support through Quality Experts; prioritize resources according to local needs
- Supervise and enforce implementation of regional/global QA processes and systems in the DSE EU Affiliate country cluster
- Assure standardized execution of Quality processes in the country cluster
- Serve as the first point of contact for all quality-related topics and issues addressed by local Quality Managers/Responsible Persons and facilitate problem-solving and decision-making
- Provide profound expert knowledge to local Quality Managers and give guidance and advice on best practices
- Provide audit and inspection preparation support to Affiliates
- Assure continuous inspection readiness
- Organize professional exchange within the country cluster and liaise with the team lead(s) of other clusters
- Lead Affiliate QA projects within the country cluster
- Closely collaborate and interact with Country Managers, Regulatory Affairs, Pharmacovigilance, and Supply Chain
- Oversee and coordinate Quality Culture activities
Personal Skills and Professional Experience:
Education:
- University/FH/Master's degree in natural or pharmaceutical sciences, preferably in Pharmacy, Chemistry, or a comparable program
Experience:
- At least 8 years of relevant work experience in the pharmaceutical industry in Quality Assurance and/or Quality Management
- Experience in leading a small team
Competencies:
- Excellent knowledge of national and international GMP/GDP regulations
- Assertiveness and strong communication skills paired with a diplomatic attitude
- Team player with high quality consciousness and a solution-oriented mindset
- Very good written and verbal communication skills in English; further European languages are an advantage
