Job Description
The Quality Supplier Manager is responsible for overseeing a wide range of activities related to the quality assurance of external suppliers involved in manufacturing activities for a product.
Key Responsibilities:
* Serve as the primary contact for all quality-related activities with external suppliers.
* Ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) regulations, as well as Sobi's quality system.
* Oversee product release, supplier qualifications, and quality technical agreements.
* Implement and maintain quality risk assessments and Key Performance Indicators (KPIs).
* Manage quality issues, audits, and change requests.
* Lead quality initiatives and act as a quality representative in projects.
Qualifications
To be successful in this position, you should have a great understanding of GMP and GDP requirements. You should be comfortable working in a global and complex environment, possess strong interpersonal and leadership skills, and be able to influence external suppliers to foster decisions and propose solutions.
* Hold a degree of at least 160 university credits in the field of 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.
* Have more than 10 years of experience within the pharmaceutical industry, with at least 5 years of experience in QA operations or external quality, including supplier quality management (GMP, GDP).
* Have an in-depth understanding of GMP requirements from FDA, EMEA, or other health authorities.
* Be familiar with risk assessment and risk management fundamentals/tools.
* Possess excellent verbal and written communication skills.
* Be fluent in English.
At Sobi, we live by our core values: Care, Ambition, Urgency, Ownership, and Partnership.
Additional Information
How to Apply
Send your application as soon as possible, including your resume in English. We have an ongoing selection process in this recruitment.
Why Join Us?
We offer a collaborative and team-oriented environment, opportunities for professional growth, diversity and inclusion, competitive compensation, and a positive impact on helping ultra-rare disease patients.
Sobi is a global company with over 1,800 employees in more than 30 countries, committed to the societies where we operate. We are a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases.
Our culture conveys that our employees are our most valuable asset. We offer a competitive benefits package to support the health and happiness of our staff.
Sobi Culture
At Sobi, we refuse to accept the status quo. 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.
By effectively turning our research into ground-breaking 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.