GMP Compliance Specialist
Vor 4 Tagen
We refuse to accept the status quo at Sobi, Inc., driven by our commitment to helping patients affected by rare diseases. Our business approach has shaped us into finding new ways of assisting those in need.
We see our focus on rare diseases as a strength, which enables us to effectively turn research into groundbreaking treatments, making medicine more accessible and opening up possibilities for patients and those caring for them.
Job DescriptionThis role involves managing a wide range of activities related to quality oversight of external suppliers in charge of manufacturing activities for products. The External Quality Manager ensures that these suppliers comply with current GMP & GDP regulations, Quality Technical Agreements, and Sobi procedures and policies.
Main Responsibilities:
- Serve as the primary contact for all quality-related activities with external suppliers.
- Ensure compliance with GMP & GDP regulations and Sobi's Quality System.
- Oversee product release, supplier qualifications, and quality technical agreements.
- 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.
Key Qualifications:
You must have a deep understanding of GMP & GDP requirements and be able to navigate complex global environments. Interpersonal and leadership skills are essential for influencing external suppliers and fostering decision-making. Strong collaboration skills are also necessary for developing relationships within Sobi and with external suppliers.
A degree of at least 160 university credits in fields such as pharmacy, medicine, or chemistry, along with relevant courses and extensive experience in QA operations or external quality, are required for this position.
An in-depth understanding of GMP requirements from FDA, EMEA, or other health authorities, as well as excellent communication skills, are essential.
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