Manager, Quality Systems & Administration

Responsibilities:
- Provide ongoing system administration, access management, configuration, and maintenance for Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, RIM).
- Ensure systems operate in compliance with cGMP manufacturing environments, GxP requirements, and internal policies; apply relevant policies, procedures, and work instructions; maintain regulatory compliance.
- Perform Business Administrator activities in Veeva Quality Management Systems, including user roles, permissions, and access controls.
- Configure Veeva Vault Quality modules (e.g., QMS, Docs, Training), managing document lifecycles, workflows, templates, and metadata.
- Assess impacts of configuration changes and/or system releases; execute user test scripts as needed.
- Coordinate with other Veeva System Leads/Administrators to ensure continuity across workstreams.
- Manage document and/or event workflows for end users.
- Manage and/or support electronic signature workflows and envelopes (e.g., DocuSign), and upload documents into Veeva QDocs for area departments.
- Support user training, onboarding, and refresher training for Veeva Vault applications; assign/revise training plans and curricula.
- Support reconciliation and archiving of paper documents.
- Identify opportunities to improve system usability, workflow efficiency, and user experience.
- Perform quality system improvement projects as needed (including Veeva eQMS).
- Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit responses.

Qualifications:
- Bachelor’s degree or higher.
- 8+ years biotech/pharmaceutical industry experience; minimum 4 years within a Quality Management Systems function (or equivalent).
- Extensive experience administering and configuring Veeva Vault Systems.
- Experience implementing Veeva Vault platforms and systems migration.

Required skills/abilities:
- Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience.
- Working knowledge of GxP processes for Veeva Quality Docs, Training, eQMS, and RIM (e.g., document change control, training, deviation management, CAPA).
- Proficiency in Microsoft Office (MS Word and Excel).
- Strong documentation, organization, and communication skills; ability to collaborate with technical and non-technical stakeholders.
- Strong planning/time management; ability to handle multiple tasks.
- Ability to work independently with minimal supervision; strong troubleshooting/problem-solving.
- Willingness to travel up to 10%.

Preferred:
- Experience managing a document archival room and coordinating off-site storage.
- Experience executing test scripts for system updates/releases.
- Experience with Veeva PromoMats and/or other EDMS/QMS/LMS systems.