RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior - Veeva Vault QMS

Job Description

Role Overview:Join EY as a Regulatory Compliance Senior in the Enterprise Risk team where you will assist clients by understanding their business needs and delivering solutions in line with EY guidelines. Your role involves establishing and maintaining relationships, driving projects to completion with high-quality deliverables, and leading internal initiatives to achieve operational efficiency.Key Responsibilities:- Configure, customize, and deploy Veeva Vault QMS modules (QRM, CAPA, Change Control, Complaints) to align with client-specific quality processes and regulatory requirements.- Design workflows, object lifecycles, security roles, and page layouts to support scalable and compliant quality operations within Vault QMS.- Collaborate with cross-functional teams to translate business requirements into robust Vault configurations and enhancements.- Lead data migration and system integration efforts to ensure seamless connectivity between Veeva Vault and other enterprise platforms.- Maintain comprehensive system documentation including configuration specifications, design documents, and user guides.- Provide expert-level troubleshooting, resolve system issues efficiently, and ensure compliance with global regulatory standards.- Participate in release management activities and offer strategic guidance to clients on Vault QMS capabilities.Qualifications:- Bachelors degree in computer science, Information Technology, or related technical discipline.- Proven proficiency in configuring Veeva Vault platform and familiarity with Veeva APIs and integration tools.- Experience in Agile/Scrum environments and strong understanding of GxP compliance and 21 CFR Part 11 requirements.- Excellent analytical, communication, and problem-solving skills.Must-Have Skills & Attributes:- 5-7 years of hands-on experience in Veeva Vault development focusing on QMS modules.- Proficiency in GAMP 5 methodology and system development life cycle.- Ability to collaborate with cross-functional teams, manage client expectations, and deliver solutions.- Strong communication, presentation, and project management skills.- Experience in troubleshooting, change control, and mentoring junior resources.- Veeva associate administrator level certification.Good-to-Have Skills & Attributes:- Exposure to business development and client engagement strategies.- Knowledge of GxP regulations and ability to contribute to thought leadership.- Experience in process optimization, technology alignment, and operational efficiency initiatives.- Strong problem-solving abilities and adaptability to changing environments.Additional Company Details:EY is dedicated to helping clients from startups to Fortune 500 companies by offering a variety of services in assurance, consulting, tax, strategy, and transactions. They emphasize employee development, high quality, and knowledge exchange in an interdisciplinary environment. EY provides support, coaching, and opportunities for skill development and career progression. Role Overview:Join EY as a Regulatory Compliance Senior in the Enterprise Risk team where you will assist clients by understanding their business needs and delivering solutions in line with EY guidelines. Your role involves establishing and maintaining relationships, driving projects to completion with high-quality deliverables, and leading internal initiatives to achieve operational efficiency.Key Responsibilities:- Configure, customize, and deploy Veeva Vault QMS modules (QRM, CAPA, Change Control, Complaints) to align with client-specific quality processes and regulatory requirements.- Design workflows, object lifecycles, security roles, and page layouts to support scalable and compliant quality operations within Vault QMS.- Collaborate with cross-functional teams to translate business requirements into robust Vault configurations and enhancements.- Lead data migration and system integration efforts to ensure seamless connectivity between Veeva Vault and other enterprise platforms.- Maintain comprehensive system documentation including configuration specifications, design documents, and user guides.- Provide expert-level troubleshooting, resolve system issues efficiently, and ensure compliance with global regulatory standards.- Participate in release management activities and offer strategic guidance to clients on Vault QMS capabilities.Qualifications:- Bachelors degree in computer science, Information Technology, or related technical discipline.- Proven proficiency in configuring Veeva Vault platform and familiarity with Veeva APIs and integration tools.- Experience in Agile/Scrum environments and strong understanding of GxP compliance and 21 CFR Part 11 requirements.- Excellent analytical, communication, and problem-solving skills.Must-Have Skills & Attributes:- 5-7 years of hands-on experience in Veeva Vault development focusing on QMS modules.- Proficiency in GAMP 5 methodology and system deve

Keyskills :
CAPAChange ControlComplaints21 CFR Part 11SDLCManufacturingLabsIT project managementChange controlMentoringTrainingTeamworkCollaborationBusiness developmentProcess optimizationOperational efficiencyTechnology alignmentVeeva Vault QM