Organizational Overview:

Immunovant is a publicly traded, clinical stage biopharmaceutical company committed to developing innovative therapies for patients living with autoimmune diseases. We are developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of multiple autoimmune diseases that are mediated by pathogenic IgG antibodies. Phase 2 clinical development is ongoing with Phase 3 preparations underway.

The Role:

Immunovant is seeking a (Senior) Quality Manager, Quality Systems to play a critical oversight role in ensuring quality/ regulatory compliance to 21 CFR Part 11/ EudraLex Volume 4 Annex 11 in the implementation (including validation) and company-wide system administration of Immunovant’s selected electronic Quality Management System (eQMS), to be implemented in 2021. In addition to being used as the company’s eQMS, the system will be used as an electronic document management system for other functional groups (e.g., CMC). The (Sr.) Quality Manager, Quality Systems will be responsible for ensuring overall system compliance to Immunovant procedures, policies, and applicable regulatory standards, guidances, and regulations.  This individual will have the unique opportunity to help grow and shape IMVT Quality, while establishing a compliant and integrated GxP QMS at a rapidly growing biotechnology company. This position will contribute to Immunovant’s success by managing eQMS implementation (including configuration and validation), day to day system use, and ongoing system validation, monitoring, and help desk activities under the guidance of the Director, Medical Devices, while working closely with the Director, Quality Operations, Information Technology (IT) and other internal functions at Immunovant and eQMS vendor staff as necessary. The (Sr.) Quality Manager, Quality Systems  will also participate in 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 system administrator.

Key Responsibilities: 

  • Participate in strategic planning regarding eQMS implementation timeline and plan, including phase-out of the company’s current eQMS, ACE
  • Develop and maintain process maps/ workflows in the eQMS as implemented in the Quality systems; lead continuous process improvement initiatives to streamline processes and improve operational efficiency
  • Act as data steward and manage master data within the eQMS system (e.g., document numbering scheme, document types, drop-down lists etc.)
  • Work with Immunovant’s IT team to create/ update GxP computer systems-specific structures (e.g., validation policy)
  • Work with Quality Operations and the IT team to create any eQMS-specific SOPs, plans, policies, and procedures as necessary, as it pertains to Immunovant’s company-wide IT structure
  • Work with the Quality team and cross-functional groups to develop eQMS-specific workflows/ procedures and create/ update SOPs (e.g., change control) accordingly
  • Work with the Quality team and cross-functional groups (as necessary) to identify and implement eQMS configurations (e.g., numbering series)
  • Work with Quality Operations to bulk upload historical documents and their metadata into Veeva
  • Work with the eQMS vendor and IT to initially validate the system, and subsequently perform periodic review of the validated state of the system and scheduled revalidations
  • Collaborate with cross-functional document owners, ensuring overall company-wide compliance to Immunovant GxP validated computer system-specific SOPs and policies, and Part 11/ Annex 11
  • Participate in meetings with regulatory bodies as needed, as an eQMS subject matter expert
  • Provide live and recorded company-wide user training programs for all user types
  • Attend training hosted by the eQMS vendor as necessary to stay current with best practices and updates to the system
  • Create training documents such as quick guides, quizzes, and walk throughs. As necessary, oversee creation and implementation of related training
  • Collaborate with Quality Operations to ensure user training and compliance (e.g., electronic signature manifest) is up to date
  • Manage issuance and control (e.g., retirement) of user licenses in a compliant and timely manner
  • Provide eQMS support services to users as needed
  • Work with the eQMS vendor and IT to resolve any help-desk issues that cannot be resolved internally
  • Work with the eQMS vendor and IT on managing/ implementing forced patches, bug fixes, and major and minor updates, as applicable
  • Perform other Quality-related responsibilities in support of the Quality team as necessary


Requirements:

  • Bachelor’s (B.S.) degree in Biology, Chemistry, IT, or related field
  • A minimum of 5-8 years of GxP Quality experience; phase 1-3 clinical trial development experience in a biopharmaceutical, biologic, or drug development environment required; commercial experience preferred
  • A minimum of 2-5 years of computer systems experience in Quality, in roles of increasing management responsibility
  • Experience with 21 CFR Part 11/ EudraLex Volume 4 Annex 11 is required; experience with GAMP 5 is preferred
  • Experience interacting with FDA and global regulatory bodies/ health authorities and pre-approval/ licensing readiness for commercial manufacturing preferred
  • Experience with building a GxP culture in a start-up biotechnology company preferred
  • Experience in immunology with clinical trials is strongly preferred
  • Experience in biologics, medical devices, and/ or combination products (particularly device-biologic combinations) preferred
  • Experience with regulatory filing structures (e.g., DHF, IND, NDA, BLA) preferred.
  • Experience with Veeva preferred
  • Strong analytical and organizational skills, with attention to detail
  • Excellent written, verbal, listening and interpersonal communication skills
  • Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants)
  • 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
  • Integrated Quality leader with ability to build strong collegial relationships cross-departmentally while effectively and courageously driving QMS initiatives

 

Work Environment: 

  • Dynamic, interactive, fast-paced, and entrepreneurial environment
  • Position may be located at either Immunovant’s New York City or Durham office; remote work environment is negotiable
  • Domestic travel required (up to 10%)
This position has been filled.