QA Process Owner (m/w/d) Change Control & Risk Management

QA Process Owner (m/w/d) Change Control & Risk Management

Role overview: Daiichi Sankyo Europe GmbH is seeking a QA Process Owner to oversee the Quality Management System (QMS) processes of Change Control and Risk Management within GMP and GDP frameworks for the EUCAN region. The role aims to standardize processes, ensure operational excellence, and maintain regulatory compliance aligned with regional and global requirements.

Roles And Responsibilities

• Act as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Change Control and Risk Management within the EUCAN region.
• Lead the regional standardization and harmonization of Change Control and Risk Management processes, ensuring compliance with GMP and GDP regulations.
• Collaborate closely with the Global Business Process Owner (BPO) of each process, serving as the Single Point of Contact (SPoC), actively contributing to the development and continual improvement of global processes.
• Maintain up-to-date knowledge of the latest GMP/GDP requirements and ensure their effective incorporation at the global level.
• Engage and collaborate with key stakeholders to understand operational needs, ensuring processes are user-friendly and support business requirements effectively.
• Partner directly with regional Process Leads to guarantee the proper functioning and compliance of assigned processes within the QMS.
• Identify opportunities for continuous improvement and independently develop and implement enhancement concepts for the assigned processes.
• Monitor process effectiveness and robustness through key performance indicators (KPIs), key quality indicators (KQIs), and other relevant metrics.
• Ensure continuous operational readiness by maintaining and updating all relevant documentation, including procedures, templates, and work instructions that support the QMS processes.
• Develop and deliver targeted training programs to ensure employees involved in the processes are proficient and compliant.
• Serve as a Subject Matter Expert (SME) during regulatory inspections and internal audits concerning Change Control and Risk Management processes.

Personal Skills and Professional Experience

• Degree in Natural Sciences, Pharmaceutical Sciences, or a related discipline, or equivalent professional qualification.
• Minimum of 5 years of professional experience in a GMP/GDP-regulated environment, with practical expertise in Change Control and Risk Management processes.
• Hands-on experience with electronic Quality Management Systems (e.g., TrackWise Digital, Veeva Quality Vault) and involvement in their implementation or maintenance.
• Advanced knowledge and skills in designing, mapping, and optimizing business processes.
• Excellent communication abilities and proven experience in managing stakeholders across complex organizational structures.
• Demonstrated success in building partnerships that drive change and deliver measurable results within complex ecosystems.
• Strong analytical thinking and meticulous attention to detail, with the capability to clearly communicate complex concepts to diverse audiences.
• Excellent organizational and project management skills.
• Comprehensive knowledge of applicable regulatory requirements from authorities such as EMA, SwissMedic, MHRA, Health Canada, and others.
• Fluency in English and German, both spoken and written.

Why work with us?

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

What we offer

• Work-Life-Balance
• Growth and Development
• Health and Wellbeing Support

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing
• Industries
• Pharmaceutical Manufacturing

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