Job Description Summary
R&D Quality Incident Manager (m/f/d)Location: Barcelona Gran Vía, Spain #LI-Hybrid
RDQ Incident Management is a centralized team governing major and critical quality incidents requiring escalation. The RDQ Incident Manager (m/f/d) will drive the assessments of quality issues raised in Research and Development to ensure appropriate escalation, notification, categorization, mitigation, and health authority reporting, as well as consistency in assessment and documentation for all quality incidents. The RDQ Incident Manager (m/f/d) will be the key liaison between quality and business stakeholders to ensure satisfactory management of quality issues.
Job Description
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.
Skills Desired
Analytical Development, Auditing, Audit Management, Business Partnering, Clinical Research, Communication, continuous improvement, Documentations, Health Authorities, Influencing Skills, Management Process, Quality Management, Risk Management
