Team Lead GMP/GDP QA Affiliate Management

Team Lead GMP/GDP QA Affiliate Management

Daiichi Sankyo Europe

Multiple Locations, Europe

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