GCP Inspection Project Manager

Are you ready to become a GCP Inspection Project Manager? The successful applicant will have will be proficient in Microsoft Project as they will be tracking for visibility and transparency.  This role is all about driving the management deliverables to support the execution a GCP inspection.  Therefore, you will drive the collection for readiness, initiate discussion, stay on track and a show a strength of character to manage effectively.  The individual will know that delays create problems, so keeping to a critical timeframe will mitigate risk.

Key requirements but not limited to:

• 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.

Your Experience:

• 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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity & Inclusion:

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

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