QA Process Owner (m/w/d) Deviation/CAPA/OOx Management

Overview

QA Process Owner (m/w/d) Deviation/CAPA/OOx Management

Posting Start Date: 01/09/2025

The Position:

We are seeking a dedicated and experienced QA Process Owner to join our Quality Management team at Daiichi Sankyo. This role will focus on overseeing the Deviation, CAPA, and Out of Specification (OOx) processes within the Quality Management System (QMS) for the EUCAN region, encompassing both GMP and GDP compliance.

Responsibilities:

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Deviation, CAPA, and OOx within the EUCAN region.
• Drive the standardization and harmonization of these processes at a regional level, ensuring alignment with both 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 contributing actively to the global process development and refinement.
• Maintain comprehensive knowledge of the latest GMP and GDP regulations and ensure their consistent integration and compliance within global processes.
• Engage proactively with internal stakeholders to understand their needs, incorporating feedback to develop practical and effective process solutions that support operational business objectives.
• Partner closely with regional Process Leads to ensure the efficient and effective operation of QMS processes.
• Identify continuous improvement opportunities independently and develop actionable plans to enhance process performance.
• Monitor process health through key performance indicators (KPIs), key quality indicators (KQIs), and other relevant metrics to ensure ongoing process robustness and effectiveness.
• Maintain up-to-date process documentation, including procedures, templates, and work instructions, to ensure operational readiness.
• Design and deliver comprehensive training programs to ensure that employees involved in the assigned processes are proficient and compliant.
• Act as a Subject Matter Expert (SME) during regulatory inspections and internal audits related to the assigned processes.

Personal Skills and Professional Experience:

• Degree in Natural Sciences, Pharmaceutical Sciences, or a related field, or equivalent professional qualification.
• Minimum of 5 years’ experience in a GMP/GDP-regulated environment, with practical hands-on experience in managing Deviation, CAPA, and OOx processes.
• Advanced skills in business process design, mapping, and optimization.
• Experience with electronic Quality Management Systems (eQMS) such as TrackWise Digital, Veeva Quality Vault, or similar platforms is highly desirable.
• Exceptional communication skills with proven success in stakeholder management across complex organizational structures.
• Demonstrated ability to build effective partnerships that facilitate change and deliver measurable results.
• Strong analytical mindset with excellent attention to detail and the ability to articulate complex concepts clearly to diverse audiences.
• Excellent organizational and project leadership capabilities.
• In-depth knowledge of regulatory requirements from authorities such as EMA, SwissMedic, MHRA, Health Canada, among others.
• Fluency in German and English, both spoken and written.