Summary
About the Role
Key Responsibilities:
• Plan, lead, conduct, document, report and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.
• For this entry-level global auditor role, audits will typically be limited to low risk GCP/PV activities such as Investigator site audits, single service vendors, sys-tems/process, Patient Oriented Programs, etc). Auditor may assist in supporting complex audits (Country Organizations, multiservice vendors, high risk vendors, etc).
• Provide technical guidance and training on audit activities.
• Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures. Ensure adequate efini-tion and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
• Maintain current knowledge of regulations, standards, and guidance documents.
Essential Requirements:
• Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience)
• Chinese (Mandarin, Catonese) fluency at operational and functional level (as first or second language; second language a plus) Proficiency in English is required
• 5 years GCP/GPvP/clinical /industry/health author-ity experience or equivalent; 1-2 years of GCP/PV auditing experience pre-ferred
• Willingness to travel up to 60% of time
• Ability to manage and objectively evaluate com-pliance issues;
• Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving;
• Good quality and compliance leadership and facilita-tion skills;
• Excellent verbal and written communication, organ-izational and interpersonal skills. Excellent computer skills, including Excel, Word, etc;
Desirable Requirements:
• Experience with Health Authority inspections and interaction a plus;
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
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