Quality Assurance Operations - Quality Manager

Quality Manager, Clinical Supply Chain Quality

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 with in 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).