Distribution & Logistics Quality Manager
Il y a 6 mois
**General Responsibilities**
Supports to ensure that all products are handled and transported in accordance with all applicable company and regulatory requirements to meet both internal and external customer demands, the product license, Good Distribution Practices (GDPs) and contractual obligations.
Reports into the Head of D&L Quality, for general advice and instruction concerning Quality Operations. Receives guidance, management, and directions, when necessary. Keeps the Head of D&L Quality informed on the status of operations and when challenges, opportunities and/or issues arise.
Directly works with an experienced team of Quality professionals in both the internal and the external network to ensure the compliant and reliable supply of our products to our patients.
**Core Responsibilities**
Provides support to ensure compliance on topics related to our global Quality Management System (QMS).
Provides quality oversight on Distribution & Logistics (D&L) operational activities, such as:
- Ensures the quality performance of assigned suppliers under D&L Quality oversight, e.g. Logistics Service Providers, Thermal Protection System (TPS) Suppliers, TPS Testing labs, Temperature Monitoring Devices suppliers
- Collaborates with internal and external stakeholders to continuously improve the performance of transportation lanes, by periodically reviewing and addressing internal and external KPIs, CAPA effectiveness and audit findings.
- Leads supplier deviation investigations within transportation, logistics & distribution.
- Manages change control requests related to D&L activities.
- Supports Internal and External Shipping Sites on the set-up and management of transportation lanes.
- Provides support to internal and external stakeholders related to GDP requirements.
- Due Diligence and collaborates with suppliers on Quality Agreement negotiation activities.
- Supports Global Auditing Team to ensure that all required external audits are planned and scheduled.
- Supports during qualification, routine, for-cause audits of suppliers / service providers to ensure compliance with Global and Local and applicable regulatory requirements, incl. review and approval of CAPA plans for audit observations.
- Participates in the launch and approval of thermal protection systems, including quality oversight requirements as per QMS related topic.
**Education Requirements**
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, Engineering or similar.
**Required Experience and Skills**
- At least 5 years of relevant work experience in the biotech/pharmaceutical industry.
- Expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GDP/GMP, regulatory requirements and good documentation practices.
- Preferably previous experience within Transportation, Distribution & Logistics
- Strong demonstrated interpersonal, communication, and leadership skills to work effectively across cultures on non-routine matters in challenging situations. Able to handle organizational complexity and ambiguity.
- Create an inclusive working environment and is a strong collaborator, including speaking candidly.
- Fluent in English.
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R289115
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