Manager, Quality Systems & Administration

Position Overview

The Manager, Quality Systems & Administration, situated within the Quality Assurance department, will provide support for the Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, and RIM) systems.

Responsibilities

• Perform Business Administrator activities in the Veeva Quality Management Systems (QDocs, Training, eQMS, & RIM), including management of user roles, permissions, and access controls.
• Provide configuration support of Veeva Vault Quality modules (e.g., QMS, Docs, Training), including management of document lifecycles, workflows, templates, and metadata.
• Participate in the assessment of impacts related to configuration changes and/or, system releases. Execute user test scripts related to system changes, as needed.
• Work with other Veeva System Leads and Veeva System Administrators to ensure continuity across workstreams
• Manage document and/or event workflows to support end users.
• Manage and/or support electronic signature workflows and envelopes (e.g. DocuSign), and document uploads into Veeva QDocs in support of area departments as needed.
• Support user training sessions, onboarding, and refresher training for Veeva Vault applications. Assign and/or revise user training plans and curricula in alignment with area department needs, as appropriate.
• Support the reconciliation and archiving process of paper documents.
• Identify opportunities to enhance system usability, workflow efficiency, and user experience.
• Perform other projects related to the improvement of quality systems as needed and required by management, including the Veeva eQMS system.
• Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities.
• Ensure compliance with all applicable policies, procedures, and regulatory requirements

Necessary Skills and Abilities

• Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience administering and configuring Veeva Vault is required.
• Working knowledge of GxP processes associated with Veeva Quality Docs, Training, eQMS, and RIM applications (e.g., document change control, training, deviation management & CAPA).
• Proficiency in Microsoft office applications, including formatting of MS Word document & Excel spreadsheets.
• Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non-technical stakeholders
• Dedicated team player who is able to withstand the high demands of a fast-paced environment.
• Excellent planning and time management skills and the ability to handle several tasks simultaneously.
• Comfortable working independently with minimal supervision.
• Strong troubleshooting and problem-solving skills.
• Excellent communication skills with the ability to collaborate across functional teams Must lead by example through strong work ethics and high standards.
• Ability for travel up to 10% of the time

Qualifications

• Bachelor’s degree or higher.
• 8+ years of experience in the biotech/pharmaceutical industry, with a minimum of 4 years situated within a Quality Management Systems function or equivalent.
• Extensive experience in Veeva Vault Systems Administration and configuration.
• Experience with previous implementation of Veeva Vault platforms and systems migration.

Preferred

• Experience in managing a document archival room and coordination with off-site storage procedures.
• Experience in executing test scripts to support system updates and releases.
• Experience with Veeva PromoMats, and/or other EDMS/QMS/LMS systems.