Clinical Quality Assurance Manager - Investigational Medicinal Product

Clinical Quality Assurance Manager - Investigational Medicinal Product

Sobi

Stockholm or Basel

About the role

As the Clinical Quality Manager, you will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams. Acting as the single point of contact for external suppliers, you will oversee manufacturing quality, ensure adherence to GMP & GDP regulations, and build strong cross-functional relationships with internal stakeholders.

Key Responsibilities

• Act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups;
• Maintain oversight of quality topics for Sobi IMPs across markets;
• Continuously improve work processes related to quality and compliance of IMPs;
• Oversee batch record reviews and release for IMPs across US, EU, and RoW clinical trials;
• Monitor and manage key performance indicators (KPIs) related to IMP supplier quality;
• Ensure compliance with Quality Agreements and support revisions in collaboration with internal teams;
• Work cross-functionally with R&D, GCP/GVP QA, QA Supplier Managers and Product Quality Leads to address and escalate IMP quality issues;
• Support supplier audits and ensure readiness for Health Authority GMP inspections.

Qualifications

About you

You are comfortable in a global and dynamic environment where priorities shift often and a highly diplomatic and tactful individual with excellent critical reasoning, risk-analysis, and problem-solving skills. Is it vital to have interpersonal and leadership skills with the ability to influence external suppliers and cross-functional teams to foster open and collaborative discussions around difficult decisions and impactful solutions.

Key Qualifications

• Bachelor’s degree or equivalent education/degree in life sciences;
• Have a solid understanding of the GMP & GDP and GCP requirements in support of IMP study;
• Minimum (10) years of experience within pharmaceutical, biotech product;
• Relevant experience from working with quality aspects of medicinal products in clinical trials, especially batch allocation and supply to clinical trials;
• Extensive experience in QA operation, production or other relevant area (GMP, GDP);
• Strong working knowledge of US and European regulations, with emphasis on Annex 13, and preferably other regions such as APAC and LATAM;
• Strong understanding of risk assessment and risk management fundamentals/tools;
• Fluently spoken and written English.

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