QA Process Owner

vor 1 Woche

München, Deutschland Daiichi Sankyo, Inc. Vollzeit

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

The Position:
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.

  • QA Process Owner

    vor 1 Woche

    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...

  • Regional QA Process Lead

    Vor 5 Tagen

    München, Deutschland Daiichi Sankyo, Inc. Vollzeit

    ** Regional QA Process Lead**(M/F/x)**eQMS** - **Roles and Responsibilities**: - Regional accountability for overseeing and enhancing eQMS system processes to ensure operational efficiency and transparency - Drive standardization of the assigned system processes - both in the area of GMP and GDP - Collaborate closely with the regional Business Process...

  • Process-owner in Successfactors Time Und Process-owner in Successfactors Employee Central Implementi

    vor 22 Stunden

    München, Deutschland Max-Planck-Gesellschaft Vollzeit

    Die Max-Planck-Gesellschaft zur Förderung der Wissenschaften e. V. (MPG) ist eine von Bund und Ländern finanzierte Selbstverwaltungsorganisation der Wissenschaft. Sie betreibt in gegenwärtig 84 Instituten und Forschungsstellen im In - und Ausland Grundlagenforschung auf natur - und geisteswissenschaftlichen Gebieten und ist damit eine der international...

  • Team Lead QA

    vor 21 Stunden

    81671 München, Deutschland TFJ buycycle GmbH Vollzeit

    **Key Facts**: - ** Start date**: March 2025 - ** Capacity**: 40 hours per week - ** Location**: Munich **buycycle & you**: We are the leading marketplace for pre-owned bikes. And to help us grow and improve, we want you on the team. We're always looking for more talent with a variety of backgrounds. **About the role**: As Team Lead QA (all genders) at...

  • Process Owner

    Vor 6 Tagen

    München, Deutschland Siemens Vollzeit

    We are looking for a strategic and experienced Process Owner to manage and own the CPQ priority (focus Price & Quote) within Siemens Sherpa X 3S business transformation program. This role is critical in shaping the global template and ensuring seamless integration across all Business Units (BUs) within the 3S scope. **What we offer you** - An attractive...

  • Process-Owner In Successfactors Time Und Process-Owner In Successfactors Employee Central Implementi

    vor 4 Wochen

    München, Deutschland Max-Planck-Gesellschaft Vollzeit

    Die Max-Planck-Gesellschaft zur Förderung der Wissenschaften e. V. (MPG) ist eine von Bund und Ländern finanzierte Selbstverwaltungs organisation der Wissenschaft. Sie betreibt in gegenwärtig 84 Instituten und Forschungs stellen im In- und Ausland Grundlagen forschung auf natur- und geistes wissenschaftlichen Gebieten und ist damit eine der international...

  • Executive Director

    vor 1 Woche

    München, Deutschland Daiichi Sankyo, Inc. Vollzeit

    For our Daiichi Sankyo European Headquarters (in Munich), we are looking for a Executive Director (M/F/x), Quality Management System R&D & PV QA - The Position: The Executive Director, Quality Management System R&D & PV QA reports to the Vice President of Quality Assurance, Global R&D & PV QA, and oversees multiple levels of direct reports (Sr Director,...

  • Process Owner Safety

    vor 4 Wochen

    München, Deutschland MAN Truck & Bus SE Vollzeit

    Process Owner Safety (w/m/d)Dein ArbeitsumfeldWir bei MAN Truck & Bus sind Teil eines starken internationalen Teams und einer der führenden europäischen Nutzfahrzeughersteller und Anbieter von Transportlösungen. Zusammen mit den Marken Scania, Volkswagen Truck & Bus und International gehören wir zur TRATON GROUP. Als Process Owner Safety...

  • Security Incident Process Owner

    Vor 3 Tagen

    München, Deutschland Knorr-Bremse Vollzeit

    **LOCATION**: München / Deutschland | **BRAND**: Knorr-Bremse Services GmbH | **DEPARTMENT**: I/CSG01 Cyber Security Governance | **REQUISITION ID**: 9115 | Full-time | Regular **About the Role**: We are seeking a **Security Incident Process Owner** to lead and continuously improve our Information Security Incident Management process in line with **ISO/IEC...

  • QA Director

    vor 2 Wochen

    München, Deutschland Virtuozzo Vollzeit

    QA Director — Kernel / Infrastructure & Automation Focus **(Remote in EU/Europe)** About Virtuozzo & the Opportunity Virtuozzo builds cutting-edge virtualization, cloud, and storage platforms powering infrastructure providers globally. As we evolve, we need a QA leader who is not just a manager, but a hardcore engineer: someone who has done...