Beschreibung

In this role, you will be the key contact for external supplier quality, overseeing supplier enrollment, performance monitoring, and quality agreements. Your day-to-day responsibilities will include managing supplier complaints, supporting audits, and ensuring compliance with regulatory standards.

Anforderungen

• •Degree in relevant business or science, or equivalent education and experience
• •Minimum of 5-8 years’ experience in GxP environment in pharmaceutical industry
• •Thorough understanding of required regulations including FDA, PiC/S, European regulation, Therapeutics Goods Authority, Canadian Health Authority
• •Demonstrated leadership and knowledge of Quality Systems and Supplier Management
• •Thorough knowledge of global cGMP regulations and ISO standards
• •Demonstrated knowledge of Quality Systems and Supplier Management
• •Comfortable working in global, matrix organization
• •Fluency in English (written and spoken); other languages (German, French) would be an asset

Aufgaben

• •Act as the local point of contact for the External Supplier Quality organization
• •Facilitate supplier enrollment and qualification
• •Revise, edit, and route Quality Agreements for signature
• •Monitor supplier performance
• •Manage supplier-related complaints and deviations, including tracking and investigation completion
• •Ensure proper acceptance of CAPA plans
• •Develop supplier improvement plans as needed
• •Support local site audits upon request
• •Make decisions based on company policies and regulatory requirements
• •Assist with supplier quality agreement activities and collaborate with team members to meet timelines
• •Contribute to the development and maintenance of the global supplier audit schedule and management tools