Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational compound, batoclimab, is a novel, fully human, monoclonal antibody targeting the neonatal Fc receptor (FcRn). Optimized as a subcutaneous injection with flexibility in dosing and approach, batoclimab is designed to reduce immunoglobin G (IgG) antibodies that cause inflammation and disease.
Immunovant is seeking a Document Coordinator, QA, to serve as a company-wide coordinator for IMVT Quality Management System (QMS) Document Control (DC) and Records Management (RM) function. The position directly reports to the Senior Manager, Document Control & Training, responsible for performing the internal customer facing technical role encompassing GxP Document Control and Records Management. Additionally, this role is key in executing the electronic document control and records management processes (Veeva) while ensuring compliance with global GxP regulations. This individual will have the unique opportunity to help grow and shape IMVT Quality Systems while specifically establishing and maintaining compliant and integrated GxP Document Control and Records Management processes at a rapidly growing biotechnology company.
The Document Coordinator, QA, provides technical guidance for and execution of, company-wide Quality Document and Records Retention processes to ensure regulatory compliance with FDA, EMA, ROW, and other applicable global health authority requirements. This role also drives consistency in format and content of controlled documents, including naming conventions and hierarchy structure, assists in developing proficiency evaluations, and executes robust records retention processes while demonstrating effective collaboration and strong adherence to Immunovant’s key value pillars.
This position will contribute to Immunovant’s success by executing the Document Control and Records Retention processes under the guidance of the Senior Manager, Document Control & Training while working closely with applicable functional areas across Immunovant and in partnership with key internal functional leads. The Document Coordinator will also contribute to strategic planning with a focus on meeting corporate quality goals, promoting a culture of quality across the company, and reflecting Immunovant’s core values as a leader.
- Serve as the Document Control and Records Management process execution Lead for company-wide documents and records (both paper and electronic), ensuring overall control and compliance, effectiveness, and efficiency of these quality systems and the electronic tool supporting them
- Ensure consistency in document format, naming and numbering, and compliance with approved document hierarchies, Policies, Quality Standards and Standard Operating Procedures
- Manage, maintain, and continuously improve IMVT’s Document Control and Records Retention processes including reporting of Key Performance Indicators
- Serve as the Document Coordinator (and power user) for Veeva Document Change Controls, including document processing and distribution.
- In partnership with Subject Matter Experts in select functional areas who maintain a small number of controlled documents, serve as the Document Coordinator for Veeva Document Change Controls.
- Support overall QA functions and Quality team in key operational areas as appropriate
- Provide support in managing the preparation, hosting, and follow-up of regulatory inspections
- Manage and/or participate in the development and/or review of standard operating procedures, forms, and work instructions
- Build collaborative pro-active relationships with cross-departmental internal stakeholders
- Perform additional Quality-related duties as assigned by Sr. Manager, Document Control & Training
- BA/BS or equivalent work experience
- A minimum of 2 years of GxP-regulated experience working within GxP Document Control or Records Control processes.
- Experience with Veeva QualityDocs as a primary full user, Veeva business administration experience heavily weighted
- Expertise with Microsoft Word software in the formatting of template based documents, fillable forms, and locked field templates
- Experience interacting with FDA, EMA, and other global health authorities is a plus
- Strong organizational skills, with attention to detail
- Excellent written, verbal, listening and interpersonal communication skills
- Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
- Ability to take initiative, prioritize and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity, and discretion at all times
- Experience with Veeva eTMF, or Veeva Process modules are a plus but not required
- Dynamic, interactive, fast-paced, and entrepreneurial environment
- Position may be located at either Immunovant’s Durham NC office or remote
- Domestic travel may be required (up to 10%)
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