393274BR
Apr 16, 2024
Mexico
About the Role
#LI:#Hybrid role
About the role:
Lead, support and report independent GCP/PV audits according to the NVS Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and documents. Review and approve corrective action plans in support of the audit observations
Main Responsibilities:
• Support the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.
• Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and documents. Perform activities with a high degree of independence.
• Assess the adequacy of responses (CAPA plans) to audit findings in agreement with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP)
• Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels as well as recommend remediation.
• Execution of the risk based Unified Quality Audit Plan (UQAP).
• Accuracy of findings and completion of audits and finalization of audit reports within established timelines, procedures and agreed upon standards/Key Performance Indicators (critical metrics). Effective analysis of audit metrics and causes of non-compliance.
• Timely customer concern through accurate channels of issues and findings that impact NVS Good Clinical Practice/Pharmacovigilance and risk benefit evaluation capabilities. Timely, complete and accurate communication, consultation and support to business partners.
• Effective facilitation and follow-up of HA inspections, as assigned. Effective collaboration on quality/compliance remediation and improvement initiatives; timely completion of projects. Timely review and feedback on policies, procedures and associated documents. Lead compliance investigations and initiatives passionate about inspection readiness and quality, process and compliance improvement as requested.
About the role:
Lead, support and report independent GCP/PV audits according to the NVS Quality System and the current GCP/PV regulations to assess compliance with applicable regulations, standards, and documents. Review and approve corrective action plans in support of the audit observations
Main Responsibilities:
• Support the strategic development of an effective global risk-based audit strategy and programme; collect, collate and incorporate input into audit strategy and plan.
• Lead, plan, conduct, document and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Novartis Quality Module as well as applicable regulations, standards, quality agreements, and documents. Perform activities with a high degree of independence.
• Assess the adequacy of responses (CAPA plans) to audit findings in agreement with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP)
• Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels as well as recommend remediation.
• Execution of the risk based Unified Quality Audit Plan (UQAP).
• Accuracy of findings and completion of audits and finalization of audit reports within established timelines, procedures and agreed upon standards/Key Performance Indicators (critical metrics). Effective analysis of audit metrics and causes of non-compliance.
• Timely customer concern through accurate channels of issues and findings that impact NVS Good Clinical Practice/Pharmacovigilance and risk benefit evaluation capabilities. Timely, complete and accurate communication, consultation and support to business partners.
• Effective facilitation and follow-up of HA inspections, as assigned. Effective collaboration on quality/compliance remediation and improvement initiatives; timely completion of projects. Timely review and feedback on policies, procedures and associated documents. Lead compliance investigations and initiatives passionate about inspection readiness and quality, process and compliance improvement as requested.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Role Requirements
Education
(minimum/desirable): • Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience)
• Advance degree desirable
Languages:
Experience:
• English fluency at operational and functional level (as first or second language; second language a plus)
• 7+ years of GCP/PV/Pharmaceutical
Industry/Health Authority experience or equivalent;
• 3 years of GCP/PV auditing experience; 5 years preferred; experienced in both GCP and PV auditing is ideal;
• Willingness to travel approximately 60% of the time.
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision;
• Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving;
• Experience with Health Authority inspections and interaction;
• Excellent quality and compliance leadership and facilitation skills;
• Excellent verbal and written communication, organizational and interpersonal skills;
• Excellent computer skills, including Excel, Word, etc;
• Extensive knowledge of applicable GCP, PV and GxP
regulations, guidelines, policies and procedures;
• Good knowledge of computer systems validation and 21CFR Part 11 requirements;
• Ability to lead audit teams and operate successfully in various team capacities;
• Excellent leadership and facilitation skills
• Ability to operate successfully in various cultural environments;
• Ability to deputize for Regional Audit Head as required;
• Auditor certification desired.
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
(minimum/desirable): • Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience)
• Advance degree desirable
Languages:
Experience:
• English fluency at operational and functional level (as first or second language; second language a plus)
• 7+ years of GCP/PV/Pharmaceutical
Industry/Health Authority experience or equivalent;
• 3 years of GCP/PV auditing experience; 5 years preferred; experienced in both GCP and PV auditing is ideal;
• Willingness to travel approximately 60% of the time.
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision;
• Ability to address a variety of tasks within the same timeframe while maintaining oversight; ability to maintain a high degree of independence with respect to decision making and problem solving;
• Experience with Health Authority inspections and interaction;
• Excellent quality and compliance leadership and facilitation skills;
• Excellent verbal and written communication, organizational and interpersonal skills;
• Excellent computer skills, including Excel, Word, etc;
• Extensive knowledge of applicable GCP, PV and GxP
regulations, guidelines, policies and procedures;
• Good knowledge of computer systems validation and 21CFR Part 11 requirements;
• Ability to lead audit teams and operate successfully in various team capacities;
• Excellent leadership and facilitation skills
• Ability to operate successfully in various cultural environments;
• Ability to deputize for Regional Audit Head as required;
• Auditor certification desired.
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Operations
QUALITY
Mexico
Ciudad de México
NOV CORPORATIVO MEX
Mexico
India
Spain
Quality
Full Time
Regular
No
