Good Distribution Practice Quality Assurance Lead

vor 5 Monaten

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

**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._

**Locations**:
Zurich, Switzerland

**Worker Type**:
Employee

**Worker Sub-Type**:
Fixed Term (Fixed Term)

**Time Type**:
Full time

  • Service Quality Assurance Manager

    vor 6 Monaten

    Zurich, Schweiz Sonova Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Design Quality Assurance Manager

    vor 6 Monaten

    Zurich, Schweiz Sonova Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Gmp Lead Auditor

    vor 6 Monaten

    Zurich, Schweiz Panda International Vollzeit

    **GMP Lead Auditor**: **Location** - Zurich, Switzerland **Business Sector** - Biotechnology **Job ref** - 22275 **Published** - 6 days ago Our client, a leading biotech company based in Switzerland, is actively seeking a highly experienced and detail-oriented GMP Lead Auditor to join their Quality Assurance team. This role is instrumental in ensuring...

  • Quality Assurance Manager

    vor 5 Monaten

    Zurich, Schweiz Sonova AG Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...

  • Mo ERP Is Functional Lead Sales

    vor 6 Monaten

    Zurich, Schweiz ABB Vollzeit

    **MO ERP IS Functional Lead Sales & Distribution (flexible location)**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities,...

  • Engineering Manager

    vor 6 Monaten

    Zurich, Schweiz KPMG Vollzeit

    Engineering Manager - Audit & Assurance - In this role, you'll represent Digital Business Technology (DBT) in our Zurich office within our Technology for Audit & Assurance team. You'll lead the delivery of data-driven solutions using automation, AI, and advocate for agile practices and reliable systems engineering with your team.**Zurich** **By...

  • Quality Assurance Associate Iii

    vor 5 Monaten

    Zurich, Schweiz Pfizer Vollzeit

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Engineering Manager

    vor 6 Monaten

    Zurich, Schweiz KPMG Vollzeit

    Engineering Manager - Audit & Assurance - In this role, you'll represent Digital Business Technology (DBT) in our Zurich office within our Technology for Audit & Assurance team. You'll lead the delivery of data-driven solutions using automation, AI, and advocate for agile practices and reliable systems engineering with your team.**Zurich** **By...

  • Project Quality Manager

    vor 4 Wochen

    Zurich, Schweiz Kanadevia Inova Vollzeit

    Company DescriptionWelcome to Kanadevia Inova, a global innovation leader in the waste infrastructure space, where we believe in creating a sustainable future through technology and innovation. Transforming Waste into ValueAt Kanadevia Inova, we pride ourselves on being at the forefront of waste-to-X technology. We are not just waste managers; we are...

  • Trading Entity Compliance QA Lead

    vor 5 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **About** the role**: - Provide leadership in the development of policy, process and organization to ensure compliant operations - Perform all the duties and have all rights applicable to the Responsible Person in Switzerland as per Swiss Medic requirements - Primary contact for local health authorities. Own relationship/communication with the local GDP...

  • Quality Assurance Manager

    vor 5 Monaten

    Zurich, Schweiz Rheinmetall Air Defence AG Vollzeit

    **Quality Assurance Manager (m/w/d)** **Rheinmetall Air Defence AG in Zürich** - Rheinmetall - / - **Quality Assurance Manager (m/w/d)** - Ref.Nr.: - **CH00672** - Anstellungsart: - **Vollzeit** - Vertragsart: - **Unbefristeter Vertrag** WOFÜR WIR SIE SUCHEN In Ihrer Position als Quality Assurance Manager (m/w/d) unterstützen Sie das Team der...

  • Quality Assurance Manager

    vor 5 Monaten

    Zurich, Schweiz Rheinmetall Air Defence AG Vollzeit

    **Quality Assurance Manager (m/w/d)** **Rheinmetall Air Defence AG in Zürich** - Rheinmetall - / - **Quality Assurance Manager (m/w/d)** - Ref.Nr.: - **CH00672** - Anstellungsart: - **Vollzeit** - Vertragsart: - **Unbefristeter Vertrag** WOFÜR WIR SIE SUCHEN In Ihrer Position als Quality Assurance Manager (m/w/d) unterstützen Sie das Team der...

  • Quality Assurance Manager

    vor 6 Monaten

    Zurich, Schweiz Panda International Vollzeit

    **Quality Assurance Manager**: **Location** - Zurich, Switzerland **Business Sector** - Biotechnology **Job ref** - 22230 **Published** - 7 days ago **QA Systems Manager - Nordschweiz** Schließen Sie sich unserem Klienten in der Nordschweiz bei einer führenden Auftragsfertigungsorganisation (CMO) im Bereich Zell - und Gentherapie an. Wir suchen einen...

  • Quality Assurance Manager

    vor 5 Monaten

    Zurich, Schweiz Rheinmetall Air Defence AG Vollzeit

    **Quality Assurance Manager (m/w/d)** **Rheinmetall Air Defence AG in Zürich** - Rheinmetall - / - **Quality Assurance Manager (m/w/d)** - Ref.Nr.: - **CH00672** - Anstellungsart: - **Vollzeit** - Vertragsart: - **Unbefristeter Vertrag** WOFÜR WIR SIE SUCHEN In Ihrer Position als Quality Assurance Manager (m/w/d) unterstützen Sie das Team der...

  • Vie Project Quality and Safety Manager

    vor 5 Monaten

    Zurich, Schweiz ALSTOM Vollzeit

    Req ID:443286 At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, more than 80 000 colleagues lead the way to greener and smarter...

  • Food Lead Auditor Junior

    vor 6 Monaten

    Zurich, Schweiz SGS Vollzeit

    **Company Description** SGS is the world's leading inspection, verification, testing and certification company. We are recognised as the global benchmark for quality and integrity. With more than 97,000 employees, we operate a network of more than 2,650 offices and laboratories around the world.** SGS is the world’s leading inspection, verification,...

  • Sdet - QA

    vor 5 Monaten

    Zurich, Schweiz OneAPPS Consulting Vollzeit

    Role: Quality Assurance Engineer with SDET Location: Zurich **Job description**: - **Experience as Quality Assurance Engineer with SDET Skillsets**, having played the role of Test Lead - **Java/Selenium/ Cucumber or TOSCA scripting experience** and working knowledge of CI/CD pipeline implementation using GitLab. Ready to be individual contributor wherever...

  • Test Spezialist Report Quality

    vor 5 Monaten

    Zurich, Schweiz coni+partner AG Vollzeit

    coni + partner ist ein seit 1993 bestehendes Beratungshaus mit Sitz in Zürich und Niederlassungen in Düsseldorf und Shanghai. Unsere Stärke ist die passgenaue Besetzung von Positionen entsprechend der Unternehmenskultur, unter genauer Betrachtung fachlicher Kompetenzen, Referenzen und «soft skills» der Kandidaten. Unser Kunde ist eine internationale...

  • Senior VP, Food Safety, Quality

    vor 6 Monaten

    Zurich, Schweiz Barry Callebaut Vollzeit

    Senior VP, Food Safety, Quality & Regulatory Location: Zurich, CH, 8005 At Barry Callebaut, we are on a journey to transform the cocoa and chocolate industry. As the world’s leading manufacturer of high-quality chocolate and cocoa products, our actions truly shape the future of our industry. We are a business-to-business company, serving the...

  • Deployment Lead

    vor 5 Monaten

    Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **Job Title**: Deployment Lead - Paperless Solutions **Location**: Zurich, Switzerland **About the role**: As Deployment Lead for the paperless implementation, you will be to supporting the global rollout of an IT solution for paperless forms and logbooks within the GxP environment. You will help drive the implementation of complex electronic logbooks,...