RC-REGULATORY COMPLIANCE-Veeva configuration-Manager

8 - 12 years

9 - 14 Lacs

bengaluru

Posted:23 hours ago| Platform:

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Skills Required

compliance project management regression testing issue resolution ai regulatory compliance business development capital markets change management qa quality management strategy development regression scrum coaching mes agile sdlc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Your key responsibilities

Lead the configuration, customization, and deployment of Veeva Vault Quality (QRM, CAPA, Change Control, Complaints), Clinical and RIM applications, ensuring alignment with pharmaceutical quality standards and regulatory frameworks.
Architect and oversee the development of workflows, object lifecycles, security models, and page layouts, enabling scalable and compliant Vault implementations.
Engage with cross-functional stakeholders (Quality, Regulatory, IT, Business) to gather and translate complex requirements into functional and strategic Vault configurations.
Direct data migration and integration initiatives, ensuring seamless connectivity between Veeva Vault and enterprise systems such as ERP, LIMS, MES and other Document Management platforms.
Establish and maintain comprehensive system documentation, including design specifications, configuration guides, validation protocols (IQ/OQ/PQ), and audit-ready deliverables.
Provide leadership in issue resolution and impact analysis, guiding teams through troubleshooting and change management processes.
Ensure system compliance with GxP, CSV/CSA, and 21 CFR Part 11 regulations, embedding validation best practices throughout the development lifecycle.
Manage release cycles and testing activities, including sandbox coordination, regression testing, and production deployments.
Act as a strategic consultant to internal and external stakeholders, advising on Vault capabilities, optimization opportunities, and digital transformation initiatives.
Mentor and lead a team of Vault developers and analysts, fostering a culture of innovation, collaboration, and continuous improvement.

Qualifications:

Bachelors degree in computer science, Information Technology, or a related technical discipline.
Proven proficiency in configuring the Veeva Vault platform, including objects, fields, roles, workflows, lifecycles, and reporting tools.
Familiarity with Veeva APIs, Vault Loader, and other integration tools for data migration and system interoperability.
Experience working in Agile/Scrum environments, contributing to iterative development and continuous improvement.
Solid understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments.
Strong analytical and problem-solving abilities, with excellent communication, client interaction, and documentation skills.

Must-Have Skills & Attributes

8 - 12 years of hands-on experience in Veeva Vault development, with deep expertise in Quality Management System (QMS) modules such as CAPA, Change Control, and Complaints.
Strong command of GAMP 5 methodology and the System Development Life Cycle (SDLC), with proven experience in validated environments.
Demonstrated ability to collaborate across cross-functional teams including QA, IT, Digital, Manufacturing, and Laboratory functions.
Proven success in client-facing roles, managing stakeholder expectations and delivering tailored Vault solutions.
Excellent communication, presentation, and stakeholder engagement skills.
Experience in IT project management, including planning, execution, and validation strategy development.
Strong analytical skills to troubleshoot application issues, perform impact assessments, and recommend scalable solutions.
In-depth understanding of change control, deviation management, and CAPA processes within regulated environments.
Thorough understanding of Regulatory Intelligence, Quality in Digital, submission management and archival, and document management processes within regulated environments.
Proven ability to mentor and lead junior team members, fostering technical growth and collaboration.
Experience in training and cross-skilling resources, enabling team agility and knowledge sharing.
A collaborative mindset with a focus on teamwork, innovation, and continuous improvement.
Veeva Associate Administrator Certification and/or equivalent platform credentials.

Good-to-Have Skills & Attributes

Exposure to business development activities, including client engagement, proposal support, and solutioning.
Solid understanding of GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11.
Ability to contribute to thought leadership, offering innovative insights and best practices in Vault implementation.
Experience in process optimization and operational efficiency initiatives, aligning technology with business outcomes.
Strategic mindset with the ability to align Vault capabilities with digital transformation goals.
High attention to detail, with strong analytical and critical thinking skills.
Adaptability to evolving regulatory landscapes and business priorities.
Strong problem-solving and decision-making abilities in complex, fast-paced environments.

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