QA Supplier Manager - CMO

QA Supplier Manager - CMO

Sobi

Stockholm, Sweden

The Quality 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 Quality 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 & 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.

Qualifications

In order to be successful in this position you should have a great understanding of the GMP & GDP requirements. You are comfortable in a global and complex environment; 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.

• Degree of at least 160 university credits (according to the old system, correspond to 240 university credits in current system) 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, Microbiology and Pharmacognosy (QP requirements).
• More than 10 years of experience within pharmaceutical, biotech product. More than 5 years experience in QA operation 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.

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