Manager, Quality Systems & Administration
Tonix Pharmaceuticals
4 days ago
Remote friendly (New Bedford, MA)
United States
Operations
Position Overview:
The Manager, Quality Systems & Administration (Quality Assurance) will support the Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, and RIM), providing system administration, access management, configuration, maintenance, and user support to maintain operational compliance with cGMP and GxP requirements.
Responsibilities:
- Perform Business Administrator activities in Veeva QDocs/Training/eQMS/RIM, including user roles, permissions, and access controls.
- Configure Veeva Vault Quality modules (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 Veeva System Leads/Administrators to maintain continuity across workstreams.
- Manage document and/or event workflows for end users.
- Manage/support electronic signature workflows and envelopes (e.g., DocuSign) and upload documents into Veeva QDocs.
- Support user training (onboarding and refresher), including assigning/revising training plans and curricula.
- Support reconciliation and archiving of paper documents.
- Identify opportunities to improve system usability, workflow efficiency, and user experience.
- Perform quality systems improvement projects (including Veeva eQMS).
- Participate in regulatory inspections and internal/supplier audits; support audit responses.
- Ensure compliance with applicable policies, procedures, and regulatory requirements.
Qualifications:
- Bachelor’s degree or higher.
- 8+ years biotech/pharmaceutical experience; at least 4 years in 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:
- Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME experience.
- Working knowledge of GxP processes for Veeva Quality Docs, Training, eQMS, and RIM (document change control, training, deviation management, CAPA).
- Proficiency with Microsoft Office (Word, Excel).
- Strong documentation, organization, and communication skills; ability to collaborate with technical and non-technical stakeholders.
- Strong planning/time management; troubleshooting/problem-solving skills.
- Ability to work independently with minimal supervision; travel up to 10%.
Preferred:
- Experience managing a document archival room and off-site storage coordination.
- Experience executing test scripts for system updates/releases.
- Experience with Veeva PromoMats and/or other EDMS/QMS/LMS systems.
Benefits (as listed):
- Medical, Dental & Vision; Life/AD&D; Short- and Long-Term Disability; Flexible Spending; Health Savings; Employee Assistance Programs.
- Pet Insurance.
- 401(k) with company match and annual discretionary stock options.
- Paid Time Off, Sick Time, and Paid Holidays.
- Career Development and Training.
Application Instructions:
- Please note: Tonix does not offer sponsorship for this role.
- Tonix does not accept agency resumes unless contacted directly by internal Talent Acquisition; do not forward resumes to employees or other locations.
The Manager, Quality Systems & Administration (Quality Assurance) will support the Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, and RIM), providing system administration, access management, configuration, maintenance, and user support to maintain operational compliance with cGMP and GxP requirements.
Responsibilities:
- Perform Business Administrator activities in Veeva QDocs/Training/eQMS/RIM, including user roles, permissions, and access controls.
- Configure Veeva Vault Quality modules (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 Veeva System Leads/Administrators to maintain continuity across workstreams.
- Manage document and/or event workflows for end users.
- Manage/support electronic signature workflows and envelopes (e.g., DocuSign) and upload documents into Veeva QDocs.
- Support user training (onboarding and refresher), including assigning/revising training plans and curricula.
- Support reconciliation and archiving of paper documents.
- Identify opportunities to improve system usability, workflow efficiency, and user experience.
- Perform quality systems improvement projects (including Veeva eQMS).
- Participate in regulatory inspections and internal/supplier audits; support audit responses.
- Ensure compliance with applicable policies, procedures, and regulatory requirements.
Qualifications:
- Bachelor’s degree or higher.
- 8+ years biotech/pharmaceutical experience; at least 4 years in 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:
- Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME experience.
- Working knowledge of GxP processes for Veeva Quality Docs, Training, eQMS, and RIM (document change control, training, deviation management, CAPA).
- Proficiency with Microsoft Office (Word, Excel).
- Strong documentation, organization, and communication skills; ability to collaborate with technical and non-technical stakeholders.
- Strong planning/time management; troubleshooting/problem-solving skills.
- Ability to work independently with minimal supervision; travel up to 10%.
Preferred:
- Experience managing a document archival room and off-site storage coordination.
- Experience executing test scripts for system updates/releases.
- Experience with Veeva PromoMats and/or other EDMS/QMS/LMS systems.
Benefits (as listed):
- Medical, Dental & Vision; Life/AD&D; Short- and Long-Term Disability; Flexible Spending; Health Savings; Employee Assistance Programs.
- Pet Insurance.
- 401(k) with company match and annual discretionary stock options.
- Paid Time Off, Sick Time, and Paid Holidays.
- Career Development and Training.
Application Instructions:
- Please note: Tonix does not offer sponsorship for this role.
- Tonix does not accept agency resumes unless contacted directly by internal Talent Acquisition; do not forward resumes to employees or other locations.