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 Quality Manager, GxP Training
to serve as a company-wide lead for IMVT’s GxP Training Program, primarily
focused on company-wide GMP, GCP and GLP training needs. The position directly reports
to the Director, Quality Operations with responsibility for leading GxP Training
with a critical role in delivering high-quality training results while ensuring
compliance with global GXP regulations across multiple indications in the
IMVT-1401 program. This individual will have the unique opportunity to help
grow and shape IMVT Quality while establishing a compliant and integrated GxP
training program at a rapidly growing biotechnology company.
The Quality Manager, GxP Training provides global GxP training oversight and direction for Immunovant GxP 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 into strategic planning for the establishment of a company-wide GXP Training Program including implementing continuous improvement efforts, reporting/escalating critical quality issues, conducting risk mitigation for training activities ensuring a complaint 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 GxP training activities under
the guidance of the Director, Quality Operations, while working closely with applicable
functional areas across Immunovant, in partnership with key internal functional
leads. The Quality Manager, GXP Training 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:
- Serve as a company-wide lead for the GXP Training Program at Immunovant, primarily focused on internal GMP, GCP and GLP training need
- Participate in strategic planning for GxP Training 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
- Evaluate the GxP training status of the company as it affects overall employee effectiveness, optimal productivity, data integrity, and reduction of deviation recurrence
- Establish the training needs of the IMVT’s GxP employees and prioritize those needs
- Work with all managers to ensure appropriate GxP curricula for each employee
- Train new employees on use of QMS GxP training database and management of their training and their training records with emphasis on GxP compliance
- Author and maintain an updated program SOP on GxP Training
- Approve all legally mandated GxP training, and ensure refresher training is conducted on at least an annual basis
- Develop, interpret, implement, and communicate corporate GxP training requirements, with escalation on training concerns as needed
- Approve the design, development and implementation of comprehensive, competency-based training programs developed by IMVT functional areas; author as appropriate
- Review and approve new and existing training programs and modules
- Manage the company-wide Learning Management System (LMS)
- Ensure that all GxP training records are maintained as required
- Approve the sourcing of GxP training aids and materials in support of departmental, company-wide, training goals; author as appropriate
- Represent the company and promote the company's position on GxP training programs, systems, and records during formal inspections by global health authorities
- Collect, review, and evaluate periodically policies, programs, and metrics to ensure alignment of training and GxP strategies with business needs
- Conduct internal site audits, including planning, executing, reporting, and follow-up to assist as needed
- Cross train in all QMS related operations systems to assist as needed
- Demonstrate initiative, prioritize, and execute tasks with minimal direction or supervision, maintaining a high-level of confidentiality, integrity, and discretion at all times
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; substantial training management, clinical & commercial experience 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
- 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
- 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
- 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%)