Senior Quality Assurance Director
hace 3 días
Welcome to a new challenge at the forefront of pharmaceutical innovation. As a Senior Quality Assurance Director - Strategic Integration, you will lead end-to-end evaluation and integration of in-licensed assets into our global network.
About the RoleWe are seeking a seasoned professional with extensive experience in QA, Production/Technical Operations, and leadership roles. Your expertise in GxP regulations, quality management systems, and due diligence assessments will be instrumental in ensuring seamless integration and compliance.
Main Responsibilities- Cross-functional Team Leadership: Establish and lead cross-functional teams, acting as a single point of contact for BD&L DD QA and supporting QA easements for corporate M&A and integration as required.
- Quality Representation: Ensure representation of QA SMEs from all necessary functions, guaranteeing comprehensive due diligence assessments across all QA LF and timely recommendations to BD&L and M&A.
- Quality Integration Plan: Develop 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 licensing partner.
- Risk Mitigation: Include risk mitigation measures from Due Diligence reports and related Quality risk analyses in the Quality Integration Plan.
- Quality Management Systems: Ensure Novartis' Quality Management Systems and applicable GxP rules are embedded in acquired or in-licensed assets.
- Communication and Partnership: Foster open and effective communication and business partnership with all stakeholders.
To succeed in this role, you must have:
- A graduate 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 at least 5 years in Quality.
- Demonstrated GxP experience and 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 spoken and written English; additional languages are a plus.
We offer a competitive salary package, benefits, and opportunities for growth and development. Our estimated salary range for this position is $236,000.
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