QA Process Owner

vor 2 Wochen

München, Deutschland Daiichi Sankyo, Inc. Vollzeit

QA Process Owner (m/w/d) Complaint Management & Recall

The Position:
Daiichi Sankyo is looking for a proactive and experienced QA Process Owner to join our Quality Management team. This role will be responsible for the oversight and continuous improvement of the Complaint Management and Recall processes within the Quality Management System (QMS) for the EUCAN region, ensuring compliance with GMP and GDP regulations.

Roles and Responsibilities:

- Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Complaint Management and Recall within the EUCAN region.
- Lead the regional standardization and harmonization of Complaint Management and Recall processes, ensuring alignment with GMP and GDP requirements.
- Collaborate closely with the Global Business Process Owner (BPO) for each process, acting as the Single Point of Contact (SPoC) and actively contributing to the development and refinement of global processes.
- Maintain up-to-date knowledge of the latest GMP and GDP regulations, ensuring their integration and compliance at the global level.
- Work collaboratively with stakeholders to understand their needs, engaging them throughout the process to ensure practical and effective solutions that support operational business requirements.
- Partner closely with regional Process Leads to ensure consistent and effective operation of the processes within the system.
- Proactively identify opportunities for process improvements and independently develop actionable concepts to implement enhancements.
- Monitor process performance through key performance indicators (KPIs), key quality indicators (KQIs), and other relevant metrics to ensure sustained robustness and effectiveness.
- Maintain continuous operational readiness by keeping documentation such as procedures, templates, and work instructions current and aligned with process needs.
- Design and deliver comprehensive training programs to ensure employees involved in the processes are proficient and compliant.
- Act as a Subject Matter Expert (SME) during inspections and audits related to the assigned processes.

Personal Skills and Professional Experience:

- Degree in Natural Sciences, Pharmaceutical Sciences, or a comparable qualification.
- At least 5 years of relevant professional experience in a GMP/GDP-regulated environment.
- Practical hands-on experience in executing Complaint Management and Recall processes.
- Advanced expertise in designing and mapping business processes.
- Experience with electronic Quality Management Systems (e.g., TrackWise Digital, Veeva Quality Vault) is an advantage.
- Excellent communication skills with proven ability in effective stakeholder management.
- Proven track record of building partnerships that inspire change and deliver results across complex ecosystems.
- Strong analytical skills and meticulous attention to detail, with the ability to communicate complex concepts effectively to diverse stakeholders.
- Excellent organizational and project leadership skills.
- Thorough knowledge of relevant regulations from authorities such as EMA, SwissMedic, MHRA, Health Canada, etc.
- Fluent in both German and English, written and spoken.

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