Gcp Inspection Project Manager

hace 4 semanas


Barcelona, Barcelona, España Novartis Farmacéutica A tiempo completo
About the Role

We are seeking a highly skilled Gcp Inspection Project Manager to join our team at Novartis Farmacéutica. As a key member of our Development Team, you will be responsible for driving the management deliverables to support the execution of GCP inspections.

The successful candidate will have a strong background in pharmaceutical quality assurance, with experience in clinical development, submission, and inspection activities. They will also possess advanced knowledge of Microsoft Project and be proficient in tracking and managing project timelines.

Key responsibilities will include defining and providing project management support to assigned Development cross-functional program teams on inspection preparation, conduct, and close-out. The ideal candidate will also have excellent communication, negotiation, and interpersonal skills, with the ability to successfully partner and communicate across all levels in the organization.

Responsibilities
  • Define and provide project management support to assigned Development cross-functional program teams on inspection preparation, conduct, and close-out.
  • Lead routine HA Inspection readiness project update meetings and tracking of line function deliverables.
  • Support RDQ/CQA in the identification of potential risks, issues, or gaps which may arise during GCP HA Inspection.
  • Maintain e-tools, systems, and repositories required for HA Inspection deliverables.
  • Collaborate with Development functions on content updates and enhancements.
  • Support line functions in the identification, preparation, and review of program-specific documents prior to HA Inspections.
Requirements
  • Bachelor's degree in life sciences/healthcare, or an advanced degree preferred.
  • 6-8 years of pharmaceutical Quality Assurance experience.
  • Solid experience of Microsoft Project.
  • Advanced understanding of the clinical drug development process and corresponding global clinical regulations.
  • Experience in clinical development, submission, and inspection activities preferred.
  • Experience in Project Management and use of MS Project.
  • Strong operational skills demonstrated excellence in execution.
  • Proven matrix leadership skills: provides direction, vision, and aligns team to deliver results.
  • Excellent communication, negotiation, and interpersonal skills.
  • Ability to successfully partner and communicate across all levels in the organization.
Why Novartis

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We believe that our employees are our greatest asset, and we strive to create a workplace that is collaborative, innovative, and rewarding.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up.



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