Process Excellence Lead
hace 2 semanas
**About Us**
At Novartis, we are committed to developing innovative solutions that improve and extend people's lives. Our goal is to become one of the industry's leading pharmaceutical companies, driving growth through innovation while maintaining the highest standards of quality, safety, and integrity.
**Job Summary**
We are seeking an experienced Process Excellence Lead - Clinical Development to join our team. The successful candidate will be responsible for ensuring compliance with Health Authorities' requirements and internal standards while driving continuous clinical process enhancements.
**Key Responsibilities**
- Actively drive a culture of Quality and successfully embed a Quality mindset across Development by forging strong business partnerships, positively impacting business deliverables, and effectively implementing the strategy, mission, and purpose of RDQ.
- Act as primary quality contact for Business Process Owners (BPOs) and actively engage with relevant RDQ representatives to provide comprehensive guidance.
- Collaborate with BPOs to conduct regulatory requirements gap assessments and implement necessary actions to address any identified gaps.
- Monitor and evaluate changes in regulations, best practices, and internal process working groups, and promptly initiate changes to clinical processes as applicable.
- Guide Quality System Owners (QSOs) and BPOs in the development of a robust strategy for clinical process changes, considering interdependencies and guide respective risk business owners in all aspects of risk management.
- Collaborate closely with BPOs to prepare for audits, actively participate, support formulating robust CAPA plan, ensuring its comprehensive review and flawless implementation.
- Collaborate closely with the Head GCP Inspection Management and GCP Inspection Project Managers when a GCP Health Authority Inspection is announced, promptly identifying potential risk areas that may impact the process.
**About the Role**
2 positions available
Primary Location: Barcelona or Madrid, Spain
Alternate Location(s): London, England / Dublin, Ireland
Working model: All locations have a hybrid working model (12 days per month in the office)
Note: Novartis is not able to offer relocation support for this role. Please only apply if the location is accessible for you.
**Estimated Salary:** €60,000 - €80,000 per year
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