Padmi

RC-REGULATORY COMPLIANCE-Digital QMS - CA Veeva-Manager

Delhi NCRPosted 3 months ago
Technology ManagementSeniorFull Time; Regular
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You will be working as a Manager at EY in the GDS Consulting Enterprise Risk (ER) Regulatory Compliance team, specifically focusing on implementing Veeva Vault Quality Management Systems (QMS) for global life sciences clients in regulated environments. Role Overview: As a Manager for Regulatory Compliance, your main responsibility will be leading Digital QMS (Veeva) implementations in regulated GxP environments. You will be leveraging your expertise in Veeva Vault to provide technical leadership within projects and mentor junior resources. Your role will involve partnering with clients to understand their business needs and translate them into compliant digital QMS solutions aligned with global regulatory standards. Key Responsibilities: - Lead and oversee Digital QMS (Veeva) Initiatives such as Deviations, CAPA, Change Control, Audit Management, Quality Risk Management (QRM), Supplier Quality, and Complaints - Design and implement workflows, object lifecycles, security roles, and page layouts aligned with client quality processes - Collaborate with various teams to translate functional requirements into compliant Vault configurations - Support data migration activities and system integrations with enterprise systems - Author and maintain comprehensive system documentation - Provide troubleshooting, system compliance, and strategic guidance to clients - Mentor junior developers and support knowledge sharing within the team - Support audits, inspections, and process harmonization across laboratories Qualifications: - Bachelors degree in computer science, Information Technology, or related technical discipline - Proficiency in configuring the Veeva Vault platform and familiarity with Veeva APIs - Experience in Agile/Scrum environments and strong understanding of GxP compliance - Strong analytical and problem-solving abilities with excellent communication skills People Responsibilities: - Lead, coach, and mentor team members - Manage work allocation and conduct performance reviews - Support hiring, training, and development planning Decision-Making Responsibilities: - Make informed decisions on delivery approach, validation strategy, and risk mitigation - Guide decisions on system design, vendor coordination, and workforce planning This is an opportunity to work with a market-leading team at EY and contribute to building a better working world by creating new value for clients, people, society, and the planet. You will be working as a Manager at EY in the GDS Consulting Enterprise Risk (ER) Regulatory Compliance team, specifically focusing on implementing Veeva Vault Quality Management Systems (QMS) for global life sciences clients in regulated environments. Role Overview: As a Manager for Regulatory Compliance, your main responsibility will be leading Digital QMS (Veeva) implementations in regulated GxP environments. You will be leveraging your expertise in Veeva Vault to provide technical leadership within projects and mentor junior resources. Your role will involve partnering with clients to understand their business needs and translate them into compliant digital QMS solutions aligned with global regulatory standards. Key Responsibilities: - Lead and oversee Digital QMS (Veeva) Initiatives such as Deviations, CAPA, Change Control, Audit Management, Quality Risk Management (QRM), Supplier Quality, and Complaints - Design and implement workflows, object lifecycles, security roles, and page layouts aligned with client quality processes - Collaborate with various teams to translate functional requirements into compliant Vault configurations - Support data migration activities and system integrations with enterprise systems - Author and maintain comprehensive system documentation - Provide troubleshooting, system compliance, and strategic guidance to clients - Mentor junior developers and support knowledge sharing within the team - Support audits, inspections, and process harmonization across laboratories Qualifications: - Bachelors degree in computer science, Information Technology, or related technical discipline - Proficiency in configuring the Veeva Vault platform and familiarity with Veeva APIs - Experience in Agile/Scrum environments and strong understanding of GxP compliance - Strong analytical and problem-solving abilities with excellent communication skills People Responsibilities: - Lead, coach, and mentor team members - Manage work allocation and conduct performance reviews - Support hiring, training, and development planning Decision-Making Responsibilities: - Make informed decisions on delivery approach, validation strategy, and risk mitigation - Guide decisions on system design, vendor coordination, and workforce planning This is an opportunity to work with a market-leading team at EY and contribute to building a better working world by creating new value for clients, people, society, and the planet.

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