Manager / Senior Manager Quality Management System & Veeva Quality Systems Administration

Karyopharm Therapeutics•Newton, MA

About The Position

Provide management-level leadership, business process ownership, Veeva Quality Suite system administration support, policy development, training, metrics, and continuous improvement for Karyopharm's core Quality Management System (QMS) functions. This position ensures QMS processes and enabling Veeva workflows, including deviations, CAPA, change control, controlled documents, training, vendor qualification, audit support, and related quality records, remain compliant, effective, inspection-ready, and aligned with business needs.

Requirements

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.

Nice To Haves

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.
Power BI, Smartsheet, or similar analytics/project tools preferred.
For Senior Manager level: prior people leadership, matrix leadership, contractor/consultant oversight, or enterprise system/process ownership experience preferred.

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.
For Senior Manager level: provide broader strategic direction for QMS/Veeva governance, lead complex enterprise or cross-functional initiatives, advise Quality leadership on priorities and risk mitigations, and coach or supervise staff, contractors, consultants, or matrixed resources as assigned.