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QA Evaluation and Integration Lead

Novartis

Novartis

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Quality Assurance
Spain
Posted on Wednesday, January 31, 2024

About the Role

Location: Barcelona.

The QA Evaluation and Integration Lead will lead the end-to-end Evaluation of “In-licensing (BD&L)” and “Merger/ Acquisition (M&A)” up to the Integration of the acquired or in-licensed asset into the Novartis network. The QA Evaluation and Integration Lead will facilitate timely decision making by QA Management including relevant line functions based on recommendation from QA SMEs and business evaluation for the holistic QA assessment covering the due diligence evaluation as well as the QA integration activities for potential external opportunities.

Key responsibilities:
• Ensure comprehensive due diligence assessments across all QA LF and timely recommendation to BD&L and M&A.
• Establish a robust Quality Integration plan with QA Line functions, members of the Quali-ty Integration Team, and collaboration with the Quality organization at the acquired company or at the licensing partner. Ensure that risk mitigation measures from Due Dili-gence reports and related Quality risk analyses are included in the Quality Integration Plan
• Ensure that Novartis’ Quality Management Systems and applicable GxP rules are embedded in acquired or in-licensed assets.
• Coordinate and compile the data for the development of the Quality Integration Budget for integration of an acquired or in-licensed asset.
• Ensure open and effective communication and business partnership with all stakeholders.
• Oversee the implementation and handover of deals by QA SMEs to the relevant LF. Provide the Quality and Technical expertise needed in the Quality Integration process.
• Prioritizes, resolves issues and ensures alignment with QA LF head, including escalation to management.
• Represent QA at BD&L DD relevant forums including but not limited to, BD&L/M&A integration Quality Review Boards (QRBs), deputize for Global Head Business Development QA where required.
• Support Health Authority Inspection readiness programs as well as internal/external audits.

This job is no longer accepting applications

See open jobs at Novartis.