Distribution & Logistics Quality Manager

il y a 1 mois

Brussels, Belgique MSD Temps plein

Job Description

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
  • Demonstrates strong problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management.
  • 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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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