Development QA Manager
- Shanghai, China
18 million Chinese patients benefit from Novartis products!
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Implement and maintain the local Quality System in the areas of GCP and GPvP, in accordance with the Novartis Quality Manual and the CPO Quality Plan.
• In cooperation with local DRA and DS&E, keep abreast of regulatory requirements, and update local management and Pharma Development MA/CPO QA on the possible ramifications of regulatory changes and impact to Clinical Development, MA and PV processes.
• Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appro-priately in order to mitigate risk.
• Conduct vendor assessment and/or qualification visits for locally outsourced clinical development, MA and pharmacovigilance (PV) activities. Ensure the ESP selection process properly followed at the CPO.
• Partner with Pharma Development QA in the preparation, execution and follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings.
• In cooperation with the local GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces.
• Participate in PH Dev QA investigation activities, as appropriate. Ensure, where appropriate, interface/communication with authorities for any GCP/PV related activity (e.g. local Health Authority [HA] inspections).
What you'll bring to the role:
• Degree in Life Sciences or related fields
• English fluent in speaking and writing.
• Min. 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, registration, clinical development or a directly related area
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
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Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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