**GERENTE QA I+D** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **W**orking at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: - Career development with an international company where you can grow the career you dream of. - A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **Established Pharmaceuticals** We are committed to bringing the benefits of our trusted medicines to more people in the world's fastest growing countries. Our broad portfolio of high-quality, differentiated brand name generic drugs spans multiple therapeutic areas, including gastroenterology, women's health, cardiometabolics, pain management/central nervous system, and respiratory. **The Opportunity** - The function is accountable for the overall Quality and Compliance during the product development life cycle processes by ensuring related practices adhere to market(s) Health Authority regulatory requirements, international regulations as well as the Abbott Quality policies. - Act as QA Single Point of Contact (SPOC) on all clinical/development project teams and act as liaison function with other QA functions. - Act as Quality SME in project teams. - Lead or participate in continuous quality improvement initiatives within I&D; QA. **What You’ll Do** - Ensure timely review and approval of development data and documents which require QA review and approval in a project Ensure timely review and approval of pivotal/CMC data and documentation QA Lead of Technical Transfers to first manufacturing site including First Lot Quality and Post Launch Review process for launch to first market Ensure timely qualification and maintain qualification status of suppliers/CMO’s/TPM’s/service providers Report project status and elevate Quality risks within the global or regional I&D; QA Governance structure. Provide Expert knowledge of global regulations and guidance’s within the I&D; team structure Act as Quality SME in Regulatory and Abbott Corporate audits Promote innovation and continuous improvement Responsible for quality compliance metrics of Development QA function Responsible for GMP QA activities in clinical supplies management processes **Required **Qualifications** - Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area **Minimum Experience/Training Required (recommended)**: Leadership & Ownership behaviors and Project management expertise combined with collaboration behavior to reach team goals Comprehensive understanding of a wide range of Pharmaceutical Lifecycle, Development, Testing and Clinical Operations, Risk Management Minimum 5 years combined experience in QA and/or Development/Operations/Pharmaceutical Engineering function in Pharmaceutical environment. Extensive knowledge of international and local pharmaceutical quality system and compliance, legislations and international and Abbott standards. Risk based, perceptual and analytical thinking related to: setting priorities, empower people, creative solutions, resources and facilities involvement. Result driven - decision maker Ability to communicate effectively, both orally and in writing for both technical and non-technical audience. Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.