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Gcp Inspection Project Manager
hace 2 meses
We are seeking a highly skilled Gcp Inspection Project Manager to join our team at Novartis. As a key member of our Development Team, you will play a critical role in driving the management deliverables to support the execution of a Gcp inspection.
Key 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.
- Ensure risks are summarized and communicated to RDQ/CQA management, RDQ Heads, Global Program Heads, and other relevant line stakeholders, as needed.
- 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 (i.e. develop storyboards, complete checklists).
- Plan and facilitate inspection preparation meetings, documentation of mitigation plans and ensure that inspection program teams are informed accordingly.
- 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 including GDD leadership as well as external stakeholders such as health authority inspectors.
- Proficient English language skills.
