Senior QA Supplier Manager

Sobi

Basel, Switzerland

The QA Supplier Manager is responsible for a wide range of activities related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product. Acting as a single point of contact with the external supplier, the QA Supplier Manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Technical Agreement and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders

Key Responsibilities:

Serve as the primary contact for all quality-related activities with external suppliers.
Ensure compliance with GMP regulations and Sobi's Quality System.
Oversee supplier qualifications, and quality technical agreements.
Release commercial products on QP Delegate
Implement and maintain quality risk assessments and KPIs.
Manage quality issues, audits, and change requests.
Lead quality initiatives and act as a quality representative in projects.

Qualifications:

In order to be successful in this position you should have a great understanding of the GMP requirements. You are comfortable in a global and complex environment; able to coordinate people to reach our goals; have interpersonal and leadership skills with ability to influence external Suppliers in a cross-functional environment to foster decisions and to propose solutions. Furthermore, you have great collaborative skills to develop strong relationship within Sobi but also with the External Suppliers

High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
More than 7 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)
Proven track record with FDA; EMEA or other Health Authorities
Strong understanding of risk assessment and risk management fundamentals / tools
Fluently spoken and written English

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