QA Evaluation and Integration Lead

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.

Essential requirements:
• Education: Degree in Chemistry, Pharmacy / Biotechnology, Microbiology or another related science or equivalent experience
• Minimum 15 years’ experience in the pharmaceutical industry, including operative experience in QA, Production/Technical Operations and/ or Development, optimally including at least 5 years in Quality. Demonstrated GxP experience and Project Management skills.
• 5 or more years of demonstrated leadership and accomplishments in an (international) matrix organization.
• Broad understanding of global expectations of health Authorities in GxP regulated areas.
• Fluent spoken & written English. Additional languages a plus
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and tru ste d medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people and culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis an d o ur career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network