Good Distribution Practice Quality Assurance Lead

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About the role:

You will perform the operational quality oversight of and provides guidance to Global and Regional Distribution Centers (GDC/RDCs) in Europe. The responsibilities cover quality aspects of warehousing, distribution and transportation, and the management of quality and compliance issues of GDC/RDCs

You will be the direct contact point for local affiliates, manufacturing sites and external supply groups for GDC/RDC quality related matter

This is a hybrid role that reports to the Head, Trading Entity Compliance.

How you will contribute:

• Guide and ensure prompt resolution of product quality and compliance issues in the assigned RDCs, in compliance to Takeda QMS and local regulatory requirements including complaints/ recalls, investigations and audit related matters.
• Drive risk identification and mitigation for processes linked to and established at the GDC/RDCs. Notification and escalation of severe GDP events to Takeda management.
• Ensure compliance to change management requirements and Falsified Medicines Directive at the GDC/RDCs and translation into the Takeda QMS. Perform and support GDP Audits at GDC/RDCs.
• Represent Takeda during regulatory agency inspections at GDC/RDCs. Support inspections at Takeda manufacturing sites related to questions for GDC/RDC.
• Evaluate the level of GMP/GDP compliance and risks for products managed by GDC/RDCs in the region through key performance indicators/quality performance indicators and guide the implementation of improvement activities.
• Participate in supporting recall activities.
• Establish or help establish Quality Agreements related to GDC/RDC's. Represent Takeda to make decisions on acceptability of distributor's and warehouse operations quality programs and daily RDC related activities.
• Support execution of quality management system activities across the TEC and CQ group- such as but not limited to Gap Assessment process/ Customer qualifications/ Self inspection.
• Implement processes and procedures to ensure that the team meets quality standards and complies with relevant regulations and requirements. Continue developing and maintaining governance frameworks to support these objectives.
• Maintain strong collaboration with Supply Chain, Site Quality Organization, GDC/RDC related LOC Quality and Takeda project teams. Important interactions with RDCs in the region to improve performance and maintain compliance, and interactions across manufacturing and site and regional quality teams to ensure issue resolution.
• Process and administrate Quality Assurance information in Takeda electronical systems e.g. SAP, Trackwise, LEADs and other electronic systems.
• Demonstrate knowledge of regulations on GDP, distribution, warehousing and transportation in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements). Understanding of Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints).

What you bring to Takeda:

• Scientific Degree (BSc, MSc)
• Minimum 10 years experience in logistics in the pharmaceutical industry, combined with a knowledge of regulations on pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
• Prior experience managing external GMP/GDP suppliers
• Experience leading GMP/GDP audits
• Fluent in written and spoken English

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.