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Good Distribution Practice Quality Assurance Lead
vor 4 Monaten
About the role:
You will be responsible for overseeing operational quality and providing guidance to Global and Regional Distribution Centers (GDC/RDCs) across Europe. Your duties will include ensuring quality in warehousing, distribution, and transportation, as well as managing quality and compliance issues at these centers.
You will serve as the primary point of contact for local affiliates, manufacturing sites, and external supply groups regarding quality matters at GDC/RDCs.
This role is a combination of responsibilities reporting to the Head of Trading Entity Compliance.
How you will contribute:
- Provide guidance and ensure timely resolution of product quality and compliance issues at assigned RDCs, adhering to Takeda's Quality Management System and local regulatory requirements.
- Identify and mitigate risks related to processes at GDC/RDCs. Report severe GDP events to Takeda management.
- Ensure compliance with change management requirements and the Falsified Medicines Directive at GDC/RDCs. Conduct and support GDP audits at these centers.
- Represent Takeda during regulatory agency inspections at GDC/RDCs. Assist in inspections at Takeda manufacturing sites concerning questions about GDC/RDCs.
- Evaluate GMP/GDP compliance and risks for products managed by GDC/RDCs in the region through key performance indicators/quality performance indicators. Guide the implementation of improvement activities.
- Participate in recall activities.
- Establish or assist in establishing Quality Agreements related to GDC/RDCs. Make decisions on the acceptability of distributor and warehouse operations quality programs as a Takeda representative.
- Support the execution of quality management system activities across the TEC and CQ group, such as Gap Assessment processes, Customer qualifications, and Self-inspections.
- Implement processes and procedures to ensure the team meets quality standards and complies with regulations. Develop and maintain governance frameworks to support these objectives.
- Maintain strong collaboration with Supply Chain, Site Quality Organization, GDC/RDC-related LOC Quality, and Takeda project teams. Interact with RDCs in the region to enhance performance and compliance. Collaborate with manufacturing and site and regional quality teams to resolve issues.
- Process and manage Quality Assurance information in Takeda electronic systems like SAP, Trackwise, and LEADs.
- Demonstrate knowledge of GDP, distribution, warehousing, and transportation regulations in the region. Understand Commercial Quality requirements, controlled substance compliance, supply chain quality, and local quality surveillance.
What you bring to Takeda:
- Scientific Degree (BSc, MSc)
- Minimum 10 years of logistics experience in the pharmaceutical industry with knowledge of regional pharmaceutical manufacturing and distribution regulations.
- Prior experience in managing external GMP/GDP suppliers.
- Experience in leading GMP/GDP audits.
- Proficient in written and spoken English.
More about us: Takeda is revolutionizing patient care through innovative specialty pharmaceuticals and top-notch patient support programs. As a patient-centric company, Takeda will motivate and enable you to thrive in impactful work. Recognized as a Global Top Employer, Takeda offers exciting career opportunities, promotes innovation, and strives for excellence. We foster a collaborative and inclusive work environment where teams are driven by a steadfast commitment to deliver Better Health and a Brighter Future worldwide. empowering our employees to excel: Takeda is dedicated to building a diverse workforce and providing equal job opportunities without regard to various characteristics.
Locations Zurich, Switzerland Worker Type Employee Worker Sub-Type Fixed Term (Fixed Term) Time Type Full time