Senior Manager, Quality Engineer

Organizational Overview:

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

Reporting to the Director, Quality Engineer (Device), this position is responsible for representing Quality on a cross-functional Device team to drive the development and maintenance of medical devices and combination products. The Quality Engineer will be responsible for participating in product development teams and executing Quality System requirements to ensure medical devices and combination products are developed, tested, and released in compliance with worldwide Medical Device Regulations. This individual will have the unique opportunity to help design and shape IMVT Quality documents for the development of medical devices in collaboration with external contract organizations at a rapidly growing biotechnology company.

In addition to these primary areas of focus, the Senior Manager, Quality Engineer (Device) will also be responsible for reviewing, and approving project documentation, specifications, design control requirements, perform risk management activities with the technical teams, perform quality activities related to product development, and ensure compliance with Immunovant’s policies and procedures. The Quality Engineer will assemble and perform a technical quality review of executed device associated documentation provided by the contract manufacturer to ensure regulatory compliance with FDA, EMA, ROW. The Quality Engineer will also facilitate identifying gaps/improvement opportunities within the Design History File and Risk Management and write/review procedures and related documents for the development of medical devices and combination products in compliance with global regulations. The Quality Engineer will apply knowledge of global regulations to assist in the preparation of and support regulatory agency and internal audits and support the creation of regulatory submission documentation.

This position will contribute to Immunovant's success by collaborating with other functional team members on providing requirements, driving design verification and validation, and human factors, along with oversight of all the DHF and risk management deliverables to ensure the safety and efficacy of new and existing products.

Key Responsibilities:

• Participate in cross-functional teams responsible for the development of drug delivery devices from initial concept generation through commercialization
• Partner with other functions including Manufacturing, Safety/Clinical, Quality, Regulatory, and Device Engineering to lead and perform risk assessments.
• Participate in the development of Design History Files (DHF) and Risk Management Files
• Participate in the develop FMEAs to ensure failure modes and patient risks are identified & mitigated; lead risk management activities; provide risk and design control input to cross-functional teams.
• Support the completion of gap assessments against industry regulations or standards
• Support device product quality investigations, CAPAs and change control activities
• Assess product complaints and standards to create robust design inputs and user needs
• Contribute to regulatory filing content related to combination products (IND, NDA, etc.)
• Support medical device and combination product inspection readiness and regulatory responses as needed
• Participate in technology transfers of combination product manufacturing to clinical and commercial manufacturing sites
• Effectively communicate ideas, project goals, and results to team members across functions and departments
• Work with marketing teams to clearly define unmet needs and User Needs for upstream product development efforts
• Perform additional quality-related duties as assigned by the Director, Quality Engineer (Device)

Requirements:

• Bachelor (B.S.) or advanced degree; preferably in sciences, engineering, or other technical/scientific area
• A minimum of 5-8 years of GMP-regulated experience working within GMP Quality systems; in roles of increasing responsibility; medical devices and combination products, clinical & commercial experience in GMP environment preferred
• Experience interacting with FDA, EMA, and other global health authorities
• Preferable experience working in the information technology QA field
• 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

Work Environment:

• Remote location
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic and international travel may be required (up to 25%) including required quarterly onsite meeting

Compensation is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Equity, sign-on bonuses, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k and other benefits, including unlimited paid time off and parental leave. The annual base salary for this position ranges from $160,000.00 - $175,000.00.