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Medicinal Products Compliance Officer
Vor 7 Tagen
About This Role:
Clinical Quality Assurance Manager at TN SwitzerlandThis is an exciting opportunity to join our team as a Clinical Quality Assurance Manager and play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs). 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.
- Lead the supplier management team to ensure timely and effective resolution of quality-related issues.
- 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.
About you:
You are comfortable in a global and dynamic environment where priorities shift often and are a highly diplomatic and tactful individual with excellent critical reasoning, risk-analysis, and problem-solving skills. It is 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.
About our company culture:
We value innovation, teamwork, and integrity.
Key Qualifications:
- Bachelor's degree or equivalent education/degree in life sciences.
- Solid understanding of GMP & GDP and GCP requirements in support of IMP study.
- Minimum of 10 years of experience within the pharmaceutical or biotech industry.
- Relevant experience 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.
How to apply:
Please submit your application including your resume in English.