MANAGER / SENIOR MANAGER QUALITY MANAGEMENT SYSTEM & VEEVA QUALITY SYSTEMS ADMINISTRATION

About the role

This position serves as the functional owner and subject matter expert for core QMS processes, including deviation management, investigations/root cause analysis, CAPA, change control, document control, training, vendor qualification, audit support, and quality metrics. It also provides day-to-day Veeva Quality Suite business administrator support for applicable modules such as Veeva QMS, QualityDocs, Vault Training, and related workflows.

Responsibilities

• Serve as the functional owner and subject matter expert for core QMS processes, including deviation management, investigations/root cause analysis, CAPA, change control, document control, training, vendor qualification, audit support, and quality metrics.
• Provide day-to-day Veeva Quality Suite business administrator support for applicable modules such as Veeva QMS, QualityDocs, Vault Training, and related workflows.
• Administer and support Veeva user access, roles, permissions, lifecycle/workflow routing, object records, document workflows, training assignments, reports, dashboards, and data-quality activities in accordance with approved procedures and role-based access.
• Partner with IT, CSV, Quality, and business process owners to assess, document, test, approve, and implement Veeva system changes while maintaining the validated state of GxP computerized systems.
• Translate business and compliance needs into process and system requirements; support enhancement requests, user acceptance testing, release impact assessments, regression testing, and post-release verification activities.
• Lead cross-functional policy development, process improvement, and system enhancement projects; build stakeholder consensus, define milestones, manage project risks, and communicate status to Quality leadership.
• Establish, monitor, and present KRIs/KPIs, dashboards, backlog reports, trend analyses, and QMS performance metrics for Quality Management Review and leadership forums.
• Develop, maintain, and deliver standardized training, job aids, and user-support tools for QMS processes, Veeva system navigation, good documentation practices, data integrity, and inspection readiness.
• Provide expert guidance and timely support to end users across departments to ensure effective use of QMS processes, compliant Veeva system execution, and right-first-time documentation.
• Author, review, revise, and maintain QMS-related procedures, work instructions, templates, system guidance, web resources, and controlled documents.
• Oversee controlled document lifecycle activities within Veeva, including stakeholder review, comment consolidation, redline resolution, review/approval workflows, periodic review, obsolescence, archival, and records management.
• Review SOPs, work instructions, forms, templates, and other GxP documents for completeness, consistency, formatting, data integrity, and adherence to company guidelines.
• Support GxP vendor qualification activities, including vendor record maintenance, qualification status review, audit scheduling/tracking, vendor documentation, and vendor quality metrics.
• Provide front room/back room support during regulatory inspections, partner audits, internal audits, and external audits, including evidence retrieval, SME coordination, auditor/auditee logistics, and response support.
• Actively identify QMS and Veeva workflow inefficiencies, recurring compliance issues, training gaps, and data-integrity risks; drive sustainable corrective and preventive improvements.

Qualifications

• B.S. in Life Sciences, Quality, Regulatory, Information Systems, or a related discipline preferred; equivalent relevant experience may be considered.
• Manager level: minimum 6 years of pharmaceutical, biotechnology, medical device, or equivalent regulated-industry experience in Quality, Quality Systems, or related GxP function.
• Senior Manager level: minimum 8 years of relevant regulated-industry experience, including demonstrated leadership of QMS processes, Veeva system administration/support, cross-functional projects, and process governance.
• Hands-on experience with Veeva Quality Suite is required; experience supporting or administering Veeva QMS, QualityDocs, Vault Training, workflows, lifecycles, reports/dashboards, permissions, and/or role-based access is strongly preferred.
• Veeva Vault Platform Administrator Certification strongly preferred or expected to be obtained within 12 months of hire/role assignment for candidates serving as business/system administrator.
• Completion of Veeva Education Services training applicable to the role is preferred, such as Vault Platform Technical Foundations, Discover Veeva Quality, and/or Administer Veeva Quality; equivalent hands-on Vault Platform and Veeva Quality configuration experience may be considered.
• Veeva Quality application-specific certification, credentials, or documented training related to Veeva QMS, QualityDocs, and/or Vault Training is preferred, when available and applicable to assigned modules.
• Experience with validated GxP computerized systems, system change control, user acceptance testing, release management, periodic review, and partnership with IT/CSV stakeholders is strongly preferred.
• Strong working knowledge of core QMS processes, including deviations, investigations/root cause analysis, CAPA, change control, document control, training, vendor qualification, audit support, and Quality Management Review.
• Knowledgeable in FDA cGMP regulations, 21 CFR Part 11/electronic records expectations, EMA, MHRA, EudraLex, ICH guidance, and other applicable Biopharma industry regulations and guidance.
• Demonstrated ability to lead cross-functional initiatives, facilitate stakeholder discussions, manage competing priorities, and communicate effectively with all levels of the organization.
• Excellent verbal and written communication skills, including procedure writing, technical writing, proofreading, presentation, and meeting facilitation.
• Excellent technical skills required; candidates must be comfortable working in and supporting users across multiple computerized systems, data repositories, reports, and dashboards.
• Experience with data review for accuracy, completeness, compliance, and data integrity; ability to convert data into actionable metrics and management-level reporting.
• Experience using Microsoft Word, Excel, PowerPoint, Visio, Adobe Acrobat Pro, and other Quality or project management tools is required; Power BI, Smartsheet, or similar analytics/project tools preferred.
• Ability to work independently with minimal supervision, exercise sound judgment, escalate risks appropriately, and maintain inspection readiness in a fast-paced GxP environment.
• For Senior Manager level: prior people leadership, matrix leadership, contractor/consultant oversight, or enterprise system/process ownership experience preferred.

Pay

The anticipated base salary range for this position is $150 K - $180 K USD.