Quality Program Team Representative
A fully integrated biopharmaceutical company is looking for a Quality Program Team Representative to join their team across Europe(Iceland, Switzerland or Germany). This organization is focused on developing and manufacturing high-quality biosimilar medicines.
- Working as a Quality program team representative
- Partner as product key expert with different department, e.g. regulatory affairs, clinical operations, manufacturing, and within Quality division to enable informed decision related to e.g. deviation management, change management etc.
- Direct and monitor Corrective and Preventive Actions (CAPA) resulting from e.g. deviation management, change management between Alvotech global sites for respective products.
- Monitor Quality along supply chain for respective products (internally/externally)
- Set definitions of appropriate product quality standards that ensure compliance of products with applicable regulatory standards and customer expectations
- Ensure compliance by monitoring e.g. product quality reviews for respective products.
Skills and Requirements
- Master´s of Science in life sciences; pharmacy, biotechnology, biochemistry, chemistry or related fields.
- At least 15 years of experience in biotech Quality, Regulatory and/or Operations.
- Quality assurance experience and knowledge of biotechnology processing and testing
- Demonstrated experience leading cross-functional teams and influencing through indirect leadership, to build collaboration and drive resolution
- Broad current Good Manufacturing Practices (cGMP) experience and knowledge, QA/QC and regulatory compliance (US and other international agencies)
- Business process management and stakeholder management skills
- Excellent written and oral communication skills in English
- Critical thinking and evaluation of process problems
- Collaborative team player
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.