R&D Quality Incident Manager (m/f/d)

Major accountabilities:

Your responsibilities will be but are not limited to:

• Ensure consistency in incident management process, and drive decisions on escalation, criticality, categorization of quality issues.
• Key SME on QEM system/process, as well as Key point of contact for guidance on QI process and determination of issue criticality and categorization of issues, next steps, and mitigating actions
• Governance of all QIs to ensure consistent process and adherence to QIM procedure.
• Prepare pre-reads/presentation and meeting minutes with issue owner.
• Provide oversight of QEM records not in scope with periodic review of records to evaluate adherence to IMT principles to ensure consistent approach.
• Lead and manage Health Authority reporting as needed to ensure reporting is completed in a compliant manner and that Novartis assures adequate responses to Health Authority inquiries.
• Support audits and inspections as needed.

Minimum requirements:

• Education: Minimum degree in Science, Engineering or relevant discipline.
• 8+ years industry experience specifically in clinical operations and clinical site management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities.
• Ability to work effectively in a matrix cross-functional environment, and strong capacity for working independently with minimal guidance.
• Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills.
• English proficiency.

Desirable requirements:

• Audits and inspections experience highly desirable.

Benefits & Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook​

Benefits in Spain include Company Pension plan; Life and Accidental Insurance; Meals; Allowance or Canteen in the office; Flexible working hours.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.​

Accessibility and accommodation: 

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in any order to receive more detailed information about essential functions of a position, please send an e-mail to inclusion.spain@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. 

You will receive: 

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.