Jobbeschreibung
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
For Daiichi Sankyo Europe GmbH we are seeking highly qualified candidates to fill the position:
Team Lead (m/f/x) CMO Management QA
Purpose of the function:
As Team Lead CMO Management QA you are responsible for leading a team of highly educated and experienced people, which act as primary contact for quality related topics to our Contract Manufacturing Organizations (CMOs) involved in Drug Linker and Drug Substance manufacturing for ADC products. Furthermore, you act as primary contact for assigned overarching, management level related topics for both internal and external stakeholders in an international and very dynamic work environment from development until end of commercial life cycle. Your tasks include day-to-day business as well as strategic related topics and objectives and require communication with different functions and management levels.
- Manage a team for quality oversight for CMOs located in Europe
- You are responsible as leader for a team of 4-6 people
- You work together with different functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to support your team to solve challenges in the day-to-day business related to CMO Management
- You set strategies for optimal day-to-day business operations for your team and make sure the expectations from internal and external stakeholders are fulfilled
- You understand the needs of your team and you are able to develop people on a personal and professional level
- You are able to interact with management level at CMOs and in case necessary you take over quality-related, overarching topics connected to CMOs
- You are able to review and evaluate documents like APQRs, PPQ reports or CTDs if required
- You support the organization during Authority Inspections in your area of responsibility and perform audits on behalf of DS at different suppliers as needed
- Act as global information distributor
- You monitor quality-related information from different markets to ensure early recognition of trends related to your area of responsibility
- You provide such information to global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures
- Participate in the further development of the corporate QM-System
- You act as a SME to help improving the global Daiichi-Sankyo QMS and global SOP landscape
- Share knowledge and expertise within the DS network to improve QA and CMO management at DS
In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, Regulatory Affairs and others to ensure consistent supply to markets with products which meet our high-quality standards at any time. This requires an extensive understanding of the pharmaceutical industry and multi-cultural work environments.
- University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Biology, Chemestry or a comparable program
- At least 8+ years of relevant work experience in the pharmaceutical industry including:
- at least 4+ years in Quality Assurance and/or Quality Management – preferable in different functions as Shop Floor QA, QA Oversight for Manufacturing Activities and/or global QA roles
- at least 2+ year experience of working in a GMP in manufacturing for monoclonal anti-bodies and/or biological APIs
- Experience with ADC manufacturing is a strong plus
- At least 4+ years experience as team leader with at least 4-5 direct reports
- Excellent knowledge of international GMP/GDP regulations
- Experience in managing relationship to C(D)Mos or external supplier organizations
- Proven track record of Project management and Leadership skills in Matrix Organizations is beneficial
- Very good knowledge of CMC regulatory and development – relevant work experience in these fields is a plus
- Understanding of manufacturing steps for Drug Linker & Drug Substance manufacturing of ADCs
- Have assertiveness, strong communication skill paired with diplomatic attitude during negotiations
- A true team player, high quality consciousness and a solution-oriented mindset
- Manage senior level relationships within the company and with external partners
- Very good written and verbal communication skills in English
- Japan and/or German communication skills is a plus
- Willingness to travel (up to 10%, domestic and international)
- Excellent Benefits
- Work-Life Balance
- Growth and Development
- Health and Wellbeing Support