Tonix Pharmaceuticals

Manager, Quality Systems & Administration

North Dartmouth, MA

No sponsorship$100k-$145kDetected 8 days ago

ExcelRecruitingIntellectual PropertyClinical TrialsGMPCommunicationProblem SolvingTime ManagementMicrosoft OfficeGxP

About the role

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.
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.
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.
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.

Requirements

8+ years of experience in the biotech/pharmaceutical industry, with a minimum of 4 years situated within a Quality Management Systems function or equivalent.
Experience with Veeva PromoMats, and/or other EDMS/QMS/LMS systems.
Perform other projects related to the improvement of quality systems as needed and required by management, including the Veeva eQMS system.
Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience administering and configuring Veeva Vault is required.

Skills

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.
Ability for travel up to 10% of the time
Bachelor's degree or higher.
Extensive experience in Veeva Vault Systems Administration and configuration.
Experience with previous implementation of Veeva Vault platforms and systems migration.

Compensation

$100,000 - $145,000 USD
Compensation & Benefits
Tonix provides a comprehensive compensation and benefits package which includes:
Retirement Savings 401k with company match and annual discretionary stock options
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.

Benefits

Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
Retirement Savings 401k with company match and annual discretionary stock options
Generous Paid Time Off, Sick Time, & Paid Holidays

Company info

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need.
TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years.
Tonix's CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg).
Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction.
Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti- Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection.
In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease.
To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.
Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines.
TONMYA is a registered trademark of Tonix Pharma Limited.
All other marks are property of their respective owners.

Equal opportunity

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law.

Visa & Work Authorization

Please note that Tonix does not offer sponsorship for this role.

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