Quality Assurance Operations
4 weeks ago
100% onsite
Job Title: Quality Manager, Clinical Supply Chain Quality
Job Description
The primary responsibility of this role is to ensure quality oversight and compliance with GMPs and GDPs (Good Distribution Practices) for Clinical Supply Chain Logistics. The role will be aligned with Global Quality and Logistics, necessitating interaction with colleagues in the UK, Ireland, and Belgium, as well as a global network of third-party vendors.
Key responsibilities include:
Supporting deviations, investigations, and CAPAs related to warehouse and logistic activities.
Assisting Clinical Supply Chain Quality and Logistics operations during internal audits, regulatory agency inspections, and third-party inspections, including warehouses in the Clinical Supply Chain Logistics network.
Supporting Vendor Quality Management, including qualification activities as assigned.
Drafting and coordinating Quality Agreements related to Clinical Supply Chain Vendors.
Assisting with additional labeling activities at warehouses, including review, approval, and release.
Managing supplies within the SAP System.
Reviewing procedural documents.
Supporting Change Control processes as needed.
Providing instruction and guidance on quality issues and serving as a resource for the business functions.
Possessing knowledge of regulatory requirements related to GMP/GDP activities performed at supported warehouses.
Bringing any information relating to the impact of regulatory changes to the attention of Quality Management.
By fulfilling these responsibilities, you will play a crucial role in ensuring the quality and compliance of Client Clinical Supply Chain.
Qualifications:
Minimum B.S. in related sciences or supply chain/logistics with 5 years experience in the pharmaceutical industry within a regulated GMP and/or GDP function.
Experience within a QA role is an asset.
Broad experience in the supply chain, manufacturing and distribution of sterile and nonsterile
products.
In-depth knowledge of GMP/GDP regulations
Strong interpersonal and organizational skills
Demonstrated leadership skills
Effective written and verbal communication
Spanish Fluency an asset, but not required
Computer proficiency such as; Microsoft Office, Inventory Management System (SAP), Quality Management System (Veeva)
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