Senior Manager, Quality Systems

Job Summary:

The Senior Manager, Quality Systems, leads the strategy, development and management of the Tonix GxP documentation and training programs. The individual in this position is responsible for overseeing the management of document lifecycle processes, record retention, and drives the establishment of training requirements and materials.

This individual assists the system administrator for the electronic document and training management systems in support of these activities and other compliant systems including QMS as well as RIM.

The Senior Manager, Quality Systems provides the appropriate QA strategic planning and collaborates cross-functionally for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities and to ensure a culture of quality and compliance and will assist with any other area as needed or directed by management.

Essential Functions:

• Oversee processes related to document control and lifecycle management, training, and records management.
• Design, execute and refine strategies for documentation and training processes.
• Identify and resolve quality and compliance challenges related to the documentation and training programs.
• Collaborate with departmental management to establish and maintain training curricula and training materials.
• Monitor training completion to ensure compliance with procedures.
• Ensure execution of staff training in the use of electronic document and learning management systems.
• Support and/or execute electronic system administrative functions for the eDMS, LMS, QMS and RIM including the evaluation and implementation of changes and support of required validation activities.
• Participate as SME in internal audits and health authority inspections and assist in preparation for regulatory inspections.
• Prepare, review and monitor metrics to ensure control of systems and drive continuous improvements.
• 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 the reconciliation and archiving process of paper documents.
• Ensure compliance with all applicable policies, procedures, and regulatory requirements.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

Necessary Skills and Abilities:

• Comprehensive knowledge of cGMP regulatory requirements relating to employee training and qualification, document control, and records management.
• 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.
• Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience administering and configuring Veeva Vault is preferred.
• Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non-technical stakeholders.
• Dedicated team player who can 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.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Ability for travel up to 10% of the time.

Educational Requirements:

Bachelor’s degree

Experience Requirements:

• 12+ years of experience in the biotech/pharmaceutical industry, with a minimum of 6 years situated within a Quality Management Systems function or equivalent.
• 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.