Job Title: Quality Supplier Manager
We encourage you to apply, even if you don't meet all the qualifications. We value diversity and want to redefine the standards of care for people with rare diseases.
Sobi is a global biopharmaceutical company transforming lives by providing innovative medicines. We have over 1,800 employees in more than 30 countries.
Job Description
The Quality Supplier Manager will oversee external suppliers' quality activities related to manufacturing. This role ensures compliance with GMP & GDP regulations, the Quality Technical Agreement, and Sobi's procedures and policies.
Main Responsibilities:
1. Be the primary contact for quality-related activities with external suppliers.
2. Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
3. Oversee product release, supplier qualifications, and quality technical agreements.
4. Implement and maintain quality risk assessments and KPIs.
5. Manage quality issues, audits, and change requests.
6. Lead quality initiatives and act as a quality representative in projects.
Requirements
To be successful, you should have a great understanding of GMP & GDP requirements. You are comfortable in a global and complex environment; have interpersonal and leadership skills with the ability to influence external suppliers in a cross-functional environment to foster decisions and propose solutions.
Degree of at least 160 university credits (according to the old system) or 240 university credits (in the current system) in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science, including courses in inorganic, organic, analytical, physical and medical chemistry, biochemistry, physiology, galenic pharmacology/pharmaceutical technology, pharmacology and toxicology, microbiology, and pharmacognosy.
More than 10 years of experience within pharmaceutical or biotech products. More than 5 years of experience in QA operations or external quality including supplier quality management (GMP, GDP).
In-depth understanding of GMP requirements of FDA, EMEA, or other health authorities.
Strong understanding of risk assessment and risk management fundamentals/tools.
Excellent verbal and written communication skills.
Fluently spoken and written English.
Additional Information
Sobi offers a competitive benefits package to support the health and happiness of our staff. We know our employees are our most valuable asset and our culture conveys that.
At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.
We see our focus on rare diseases as a strength. By effectively turning our research into groundbreaking treatments, we help make medicine more accessible and open more possibilities for patients and their caregivers. This has been our approach since day one, but we know we can't change the world of rare diseases on our own.