Position Overview:
Manager, Quality Systems & Administration (Quality Assurance) supporting Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, RIM). Provide system administration, access management, configuration, maintenance, and user support to maintain compliance in cGMP/GxP environments and internal policies. Manage reconciliation/archiving of paper documents, electronic signature workflows (e.g., DocuSign), and uploads into Veeva QDocs. Collaborate cross-functionally on continuous improvement and workflow enhancements.
Responsibilities:
- Administer Veeva QMS systems (QDocs, Training, eQMS, RIM): user roles, permissions, access controls.
- Configure Veeva Vault Quality modules (QMS/Docs/Training): document lifecycles, workflows, templates, metadata.
- Assess impacts of configuration changes/releases; execute user test scripts.
- Manage document/event workflows for end users.
- Support electronic signature workflows/envelopes and document uploads.
- Run user training/onboarding/refresher training; update training plans/curricula.
- Support reconciliation/archiving of paper documents.
- Improve system usability/workflow efficiency/user experience.
- Support quality systems projects (including Veeva eQMS).
- Participate in regulatory/internal/supplier audits and audit responses.
- Ensure compliance with policies, procedures, and regulatory requirements.
Qualifications/Skills:
- Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME experience.
- Working knowledge of GxP processes for Veeva Quality Docs/Training/eQMS/RIM (e.g., change control, training, deviations, CAPA).
- Microsoft Office proficiency (Word/Excel).
- Strong documentation, organization, communication, troubleshooting, planning, and ability to work independently.
- Travel up to 10%.
- Bachelorβs degree+; 8+ years biotech/pharma; 4+ years in Quality Management Systems.
- Extensive Veeva Vault administration/configuration; experience implementing Veeva Vault and system migrations.
Preferred:
- Document archival room/off-site storage coordination.
- Experience executing test scripts for updates/releases.
- Experience with Veeva PromoMats and/or other EDMS/QMS/LMS.
Benefits (as listed): medical/dental/vision, life/AD&D, disability, FSAs/HSA, EAP, pet insurance, 401k match + stock options, paid time off/holidays, career development & training.
Application instructions: Tonix does not offer sponsorship for this role.