The client is going through huge change, comes huge opportunity. So, wherever you join us, you'll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions.
It's so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, that's exactly what's happening. R&D is the driving force for our bold new vision.
Join us and you'll have the resources, support and technology you need to break new ground and see ideas come to life. You'll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you're creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions.
As a Senior Supplier Quality Lead you will be responsible for the end-to-end management, oversight and qualification of the assigned Life Sciences related Suppliers in alignment with Company strategies and business needs, to ensure that quality of the services provided are continuously in compliance with applicable regulations, global standards, quality and compliance requirements, and contractual agreements.
Role responsibilities:
- Lead the qualification of the assigned GxP Suppliers applying a strategy based on risk evaluation, to ensure the quality of the services provided comply with applicable regulations (e.g. FDA, ICH (GCP/GCLP) etc.), standards, quality and compliance requirements and contractual agreements, and is in alignment with client strategies.
- Develop and maintain a collaborative and effective partnership with the assigned suppliers to ensure continuous improvement initiatives are supported and adhered to by the organization.
- Perform quality audits to the suppliers, by using a risk-based evaluation strategy and by ensuring audit schedule Follow-up adherence to the agreed on CAPA plans and implementation timelines.
- Oversee and monitor supplier quality performance based on the predefined metrics, supervise and contribute to the supplier Change Control, Non-Conformity and Complaint processes for the assigned Suppliers to ensure continuous compliance and to foster continuous improvement of the services provided.
Role requirements:
- Bachelor's/Master's degree in Science, Engineering or equivalent (i.e.
Chemistry, Physics, Pharmaceutical / Material Science, etc.)
- Substantial Quality Assurance experience in GxP/ISO regulated, life sciences environment, in supplier management, development & Auditor Certification and/or auditing experience in GxP fields (e.g. GCP, GCLP)
- Excellent verbal and written communication skills, strong negotiation skills. Highly organized with strong attention to details, superior follow-up and follow-through skills. Good project management knowledge. Result oriented, self-motivating, priority setting, analytical thinking, problem solving, decision making, proactive behavior, pragmatic and customer focused
- Sound understanding of statistics and data interpretation
- Advanced user level of MS Office applications
- Fluent in written and verbal English, additional languages are an
advantage.
