Manager, Quality Systems

Position Overview:

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

This position will be responsible for providing ongoing system administration, access management, configuration, and maintenance activities, as well as user support, and ensuring these systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies.

They will ensure consistent application of policies, procedures, and work instructions associated to these systems, as well as adherence to regulatory requirements.  

This position will also manage the reconciliation and archiving process of paper documents, electronic signature workflows (e.g. DocuSign), document uploads into Veeva QDocs in support of area departments as needed.

The Manager, Quality Systems & Administration will collaborate cross-functionally for on-going activities in support of continuous improvement initiatives system and workflow enhancements and assist in any other area as needed or directed by management.

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 preferred.
• 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.