Immunovant is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.
Immunovant is seeking a Head of Quality to play a key role in connection with highly dynamic cross-functional clinical development and manufacturing teams. The individual in this position will have the unique opportunity to grow and shape the quality team at a rapidly growing biotechnology company.
This position will contribute to Immunovant’s success by managing the GxP quality systems required to monitor the quality of the clinical and CMC functions at Immunovant, including third-party clinical and CMC vendors.
SUMMARY OF KEY RESPONSIBILITIES:
The position will provide strategic direction and oversight for quality systems as well as the implementation of quality policies and procedures at Immunovant. The Head of Quality will ensure that internal processes and metrics are aligned to create a high level of clinical and product quality and consistency. She or he will substantially strengthen quality systems to (a) govern Immunovant as a sponsor and (b) ensure Immunovant’s vendors and suppliers deliver the highest quality services and products.
This role maintains a comprehensive and contemporary understanding of GxP (cGMP, GCP, GLP) regulations and approval strategies for biological products to support sustainably compliant and operationally excellent development and manufacturing of Immunovant products. The Head of Quality will be responsible for leading teams across sites in an integrated, cross-functional way that supports GxP principles in the delivery of business unit goals.
The Head of Quality will serve as a mentor and coach to Quality management personnel, modeling behaviors and leadership aligned with Immunovant company values.
- Head up the strategic oversight of the Immunovant QA function.
- Overall responsibility for Immunovant’s compliance with FDA, and EMA quality-related requirements.
- Ensure that Immunovant, its contractors and vendors are prepared for FDA and other health authority audits. Coordinate and host all GxP inspections.
- Act as a primary catalyst for product life cycle improvements for all Immunovant products and processes by analyzing gaps and presenting opportunities for improvement.
- Interpret FDA and international guidelines and regulations; anticipate regulatory concerns and integrate change as appropriate to ensure compliance at a company that makes substantial use of outside vendors.
- Lead the development and reporting of quality metrics and periodic reporting depicting GxP compliance trends and any areas of risk with associated mitigation plans.
- Strategize on new product designs and product design changes as it relates to quality assurance.
- Establish quality and risk policies.
- Manage and ensure complaint investigations and CAPA systems compliance to regulatory requirements.
- Oversee development, implementation and documentation of staff training curricula.
- Provide weekly reports to senior executive management, as necessary to define and correct deficiencies identified.
- Ensure senior management reviews take place on a regular schedule.
- Ensure compliance with European quality guidance and Qualified Persons (QP) requirements.
- Oversee documentation control, CAPA and complaints processes.
- Prepare quality-related budgets and execution of the budgets.
- Organize and promote company-wide quality system improvement efforts.
- Direct and implement internal audit program to ensure that quality system objectives are met.
- Lead strategies for an effective document control system.
- Provide guidance and oversight for any recalls, complaints, and regulatory reporting.
REQUIRED QUALIFICATIONS AND SKILLS:
- Ph.D. or master’s level degree in a scientific/technical discipline.
- Minimum of 10 years’ experience in the biotechnology/biopharmaceutical/ pharmaceutical industry with biologic pharmaceutical products intended for human use
- 5+ years’ experience working in progressively responsible positions in quality
- Direct experience with significantly improving quality systems along with experience executing a quality plan
- Experience directly interfacing with regulatory agencies (e.g., FDA, EMA)
- Direct experience with interfacing with the FDA and EMA during PAI inspections.
- Direct interactions around PAI preparation.
- Strong understanding of GMP, including 21 CFR 210 & 211, ICH guidelines and FDA requirements for pharmaceuticals
- Strong experience with GCPs by managing a Clinical Operations Team or similar.
- Experience working with preclinical teams and proficient in protocol and report review.
- Experience with external and internal auditing. (GMP, GCP and GLP)
- Quality assurance experience, including final closure review of deviation/non-conformance investigations and batch disposition determination
- Extensive experience with CMO, CTLs and packaging/labeling
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro
- This position will be based in Immunovant’s New York City office
- Strong analytical and organizational skills
- Excellent written, verbal and interpersonal communication skills
- Ability to professionally interface with senior-level executives, staff, external partners and consultants
- Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment
- Ability to take initiative, prioritize and execute tasks and special projects with minimal direction or supervision, maintaining a high-level of confidentiality, integrity and discretion at all times
- Travel requirements: approximately 30% (both national and international)