Summary
Strong focus to act as Quality Integration Lead (QIL) to lead the Quality integration of an acquired or in-licensed asset into the Novartis network.
In line with the Novartis Quality standards, the QIL will establish a robust Quality Integration plan with directions of QA Line functions, members of the Quality Integration Team, and collaboration with the Quality organization at the acquired company or at the licensing partner. He/she will ensure timely execution of quality integration activities and will report progress to the Quality Integration Office and Integration Governance Boards, including on related remediation plans usually submitted as Novartis commitments to various Health Authorities.
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 (DD) evaluation as well as the QA integration activities for potential external opportunities.
About the Role
Major accountabilities:
- Ensure that Novartis’ Quality Management Systems and applicable GxP rules (FDA, EMA and other Health Authorities) are embedded in acquired or in-licensed assets.
- Set up a Quality Integration Team consisting of QA Line functions, and develop, lead and coordinate quality integration activities starting with handover from DD QA, Integration Planning, Integration Execution and Reporting.
- Establish a robust Quality Integration plan with QA Line functions, members of the Quality Integration Team, and collaboration with the Quality organization at the acquired company or at the licensing partner. Ensure that risk mitigation measures from Due Diligence 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 the acquired company.
- 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 or facilitate input from SMEs where specialist knowledge is required.
- Prioritizes, resolves issues and ensures escalation to management.
- Establish and lead cross-functional teams and act as single point of contact for BD&L DD QA and support QA assessments for corporate M&A and integration projects as required. Ensure representation of QA SMEs for all necessary functions.
- Ensures comprehensive due diligence assessments across all QA LF and timely recommendation to BD&L and M&A.
- Represent QA at BD&L DD relevant forums as determined by management
- Support Health Authority Inspection readiness programs as well as internal/external audits.
- Contribute to the continuous improvement within area of responsibility.
Minimum Requirements:
- Graduate in Chemistry, Pharmacy / Biotechnology, Microbiology or another related science or equivalent experience.
- Minimum 10 years’ experience in the pharmaceutical industry, including operative experience in QA, Production/Technical Operations/R&D, including at least 5 years in Quality. Demonstrated GxP experience.
- Broad understanding of global expectations of health Authorities in GxP regulated areas.
- 5 or more years of demonstrated leadership and accomplishments in an (international) matrix organization.
- Fluent English, written and spoken.
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 trusted 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.
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: 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.
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
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: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
