Product Owner Quality

vor 7 Monaten

Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit

As Product Owner Quality (POQ) you are responsible for ensuring quality oversight for one product at a global level. You act as primary quality contact for the assigned product for both internal and external stakeholders in an international and very dynamic work environment from development until end of commercial life cycle. To do this, you communicate with different functions on management and senior levels in day-to-day business and maintain a strategic overview of quality-related topics and objectives at the same time.

**Roles and responsibilities**:

- **Manage global quality oversight for the assigned product**
- You are responsible as global quality lead for the assigned product
- You work together with different functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to define the strategical approach to solve challenges in the day-to-day business
- You review and evaluate documents like APQRs, PPQ reports or CTDs
- You trend the development of the assigned product from a quality-related perspective and keep the senior management and the team informed about respective developments
- You identify quality risks related to the assigned product and in case necessary you escalate issues to senior level management
- You keep close contact to the teams managing the manufacturers as well as the MAH related functions
- You support the organization during submissions in GMP-related matters and if required during Authority Inspections related to the assigned product
- **Act as global information distributor**
- You monitor quality-related information from different markets and clinical studies to ensure a consistent global understanding of the assigned product
- You support global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures
- You collect and share quality related information in all directions to our global stakeholders within the global QA environment as well as in department overarching teams
- **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.

**Personal Skills and professional experience**:

- University/FH/Master degree in natural or pharmaceutical sciences - preferred in Pharmacy, Biotechnology, Microbiology 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 activities, QA Oversight for Manufacturing Activities and/or global QA roles
- at least 2+ year experience of working in a GMP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates or in manufacturing for biological APIs
- Experience with ADC manufacturing is a strong plus
- Excellent knowledge of international GMP/GDP regulations
- Proven track record of Project management and Leadership skills
- Very good knowledge of CMC regulatory and development - relevant work experience in these fields is a plus
- Expertise in Supply Chain and global demand planning is desired
- Have assertiveness, strong communication skill paired with diplomatic attitude during negotiations
- A true team player, high quality consciousness and a solution-oriented mindset
- Combine a “Hands-on” mentality with strategic thinking
- 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
- Experience with managing CMOs or external suppliers is beneficial
- Willingness to travel (up to 10%, domestic and international)

**Why work with us?**:

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