Quality Systems (Veeva) Senior Consultant

Clarkston Consulting • Raleigh, NC

11d • Remote

About The Position

Clarkston Consulting is seeking a motivated, self-driven leader to deliver business solutions to clients in the life sciences, consumer products, and retail industries. The Quality Systems (Veeva) Senior Consultant participates in client projects to design and deploy Veeva solutions, including configuration and implementation of the Veeva Quality suite and Veeva Vault RIM capabilities. The role leads requirements workshops and designs, prototypes, configures, and documents content management and QMS data solutions.

The consultant develops trusted client relationships, creates and oversees project or workstream plans and timelines, defines deliverables, assigns team roles and resources, tracks issues and resolutions, and helps manage scope and requirements. Responsibilities also include supporting computer-system validation for GMP environments, creating and revising SOPs, training end users, transferring knowledge, and guiding junior systems analysts and client personnel.

Travel is an integral part of the role and averages an estimated 30–50%, varying with client and project needs. When not at a client site, consultants work from their home office. Relocation is not required.

Requirements

• 5+ years of experience working with or for life sciences companies.
• Experience implementing Document or Quality Management systems for life sciences as a consultant, business representative, or IT representative.
• Understanding of global quality requirements, compliance considerations, and processes.
• Firsthand experience with systems such as Veeva Vault, EtQ, TrackWise, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, or other quality information or content management systems.
• Team Lead experience.
• Flexibility and adaptability, including the ability to work on tasks from design through hands-on configuration and stretch into new roles.
• Thorough client services orientation and experience taking an active role in executing engagements and project plans or tasks.
• Excellent analytical skills and the ability to present and write at publication-quality level to communicate findings and recommendations.
• A 4-year degree from an accredited college or university.

Nice To Haves

• Experience with regulatory information management systems, including registrations and submissions.

Responsibilities

• Participate in projects at life sciences and consumer products companies designing and deploying Veeva.
• Support configuration and implementation of the Veeva Quality suite and Veeva Vault RIM capabilities.
• Lead requirements workshops; design, prototype, configure, and document content management and QMS data solutions.
• Build trusted client relationships that extend beyond the project lifecycle.
• Create and oversee project or workstream plans and timelines; define deliverables; assign team roles and resources; identify and track issues and their resolution; and help manage project scope and requirements.
• Assist with computer-system validation for use in a GMP environment and create and revise SOPs.
• Conduct knowledge transfer and end-user training, including sharing best practices.
• Provide guidance to junior systems analysts and client personnel assigned to projects.

Benefits

• Comprehensive health and wellness benefits, including medical, dental, vision, and more.
• 401k with company contributions.
• Paid vacation, personal days, holidays, and sick leave.
• Paid parental leave and family-building benefits, including adoption, surrogacy, and infertility support.
• Life and disability insurance.
• Training and professional development investments and tuition assistance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior