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:
The Quality Manager, QA provides management
support for company-wide Immunovant Quality Operations to ensure regulatory compliance
with FDA, EMA, ROW and other applicable global health authority requirements
that ultimately ensure patient safety. This
role also provides input to strategic planning for implementing continuous
improvement efforts, reporting/escalating critical quality issues, conducting risk
mitigation for QMS activities ensuring a compliant culture of quality through
effective management with strong adherence to Immunovant’s key value pillars.
This
position will contribute to Immunovant’ s success by managing IMVT’s QMS and DC
activities under the guidance of the Director, Quality Operations, while
working closely with applicable functional areas across Immunovant and in partnership
with key internal functional leads. The Quality Assurance Manager 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 a leader.
Key Responsibilities:
- In close collaboration with the Director, Quality Operations, serve as a QA management lead for company-wide QMS and DC, ensuring overall control and compliance, effectiveness, and efficiency of these quality systems
- Perform and oversee key functions within IMVT’s QMS; including
document control (DC), change control, deviation/investigation/CAPA management,
and risk management in compliance with GxP regulations and the company policies/procedures
- Partner with QA Medical Devices to support QMS governance for medical devices
- Manage, maintain, and continuously improve of IMVT’s GXP QMS as process facilitator for quality assurance in Quality Operations
- Manage all aspects of document control, including but not limited to implementing and administering current and new automated electronic systems
- Compile/prepare trend reports for management review of Quality performance metrics
- Support overall QA functions and Quality team in key operational areas as appropriate
- Assist 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, policies, forms, and executable work instructions to support IMVT’s QMS
- Conduct internal site audits and external vendor audits as assigned, including planning, executing, reporting, and follow-up/closure of audit CAPAs
- Identify areas of deficiency and trends in Quality escalating to management as needed, while developing, modifying, and utilizing tools to track and trend compliance issues
- Develop timelines with functional leads to ensure timely and appropriate follow-up in areas of deficiency
- Maintain adequate, compliant records to support quality processes and audits
- Encourage an environment for ‘Quality Right First Time’ by building in efficiencies as necessary from a systematic and compliance perspective
- Build collaborative pro-active relationships with cross-departmentally both internal and external to promote and lead timely resolution of planning, open issues and efficient follow-up/evaluation for agreed CAPAs
- Perform additional Quality-related duties as assigned by Director, Quality Operations
Requirements:
- Bachelor (B.S.) or advanced degree in Biology, Chemistry, Immunology or related fields
- A minimum of 5-8 years of GxP-regulated experience working within GxP QMS systems; in roles of increasing management responsibility; substantial QMS/DC, clinical & commercial experience in GMP environment preferred
- A minimum of 2-5 years in roles of increasing management responsibility in Quality with clinical and/or commercial experience; biopharmaceutical environment preferred
- Experience interacting with FDA, EMA, and other global health authorities
- Experience with building a GxP culture in a start-up biotechnology company preferred
- Experience in immunology with clinical trials is strongly 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 may be required (up to 10%)