We are now recruiting a QA Supplier Manager for Sobi.
Sobi is an international biopharmaceutical company focused on rare diseases. The company is dedicated to providing access to innovative treatments that transform life for people with rare diseases. Today, Sobi employs approximately 1,500 people across Europe, North America, Middle East and Asia. In 2021, Sobi's revenue amounted to SEK 15.5 billion.
The Sobi share (STO:SOBI) is listed on Nasdaq Stockholm.
Sobi focus on two therapeutic areas – Haematology and Immunology – and also have a portfolio of Specialty Care products.
This is a great opportunity to join Sobi as a senior Quality Assurance professional for the externally manufactured medicinal products operations. This role means working with a wide range of tasks and in close collaboration with Sobi’s external parties throughout the whole manufacturing process, in order to ensure GMP compliance and product quality. As a QA Supplier Manager, you will be part of the global Sobi Quality Assurance team reporting to Sobi HQ, Stockholm.
Act as an expert/advisor for the organization and product teams in GMP/GDP related topics.
Pursue compliance and quality related topic both internally and externally with suppliers/CMOs (Contract Manufacturing Organization)
Be the QA representative in project teams for e.g. tech transfers or launches of product to new markets.
Handle and assess deviations, change controls and support in product complaint investigations
Release of products on QP Delegate
Participate and support both external and internal audits including also authority inspections.
Develop quality assurance standards and company processes
You will report to Head of QA EU, QP at Sobi
Pharmacist Degree or other higher education on master’s level eligible for Qualified Person (as defined in HSLF-FS 2021:102 and Article 49 of Directive 2001/83/EC)
At least 7 years’ experience in the healthcare/pharmaceutical industry, gained preferably from Quality Assurance roles in a manufacturing environment and QP/QP-delegated tasks.
Strong GMP knowledge and experience in manufacturing of sterile medicinal products and API. Beneficial with experience from biological medicinal products.
Previous experience from GMP/GDP and outsourced activities for manufacturing of medicinal products is particularly meritorious.
Excellent English langue skills (both written and verbal communication.)
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