Senior Manager/Associate Director, CMC QA

Summary

Join Immunovant, a clinical-stage immunology company, as a Sr. Manager/Associate Director, CMC Quality Assurance - Lot Disposition. You will oversee the disposition of clinical drug products, building relationships with internal and external partners to ensure a reliable medicine supply. This role involves collaborating with internal partners to ensure correct product distribution and escalating release issues to Quality Management. You will conduct final disposition of finished drug products, ensuring patient safety and compliance with global health authority requirements. The position requires applying regulatory knowledge to create and approve clinical packaging and labeling materials, providing expertise to improve processes and mitigate risks. You will maintain a culture of quality and compliance through effective leadership and adherence to company values. The position offers a remote work environment with potential for domestic travel.

Requirements

• Bachelor (B.S.) or advanced degree; preferably in in Biology, Chemistry, Engineering, or related fields
• A minimum of eight (8) years of GMP experience with a focus on Quality Assurance (QA) with substantial operational experience in drug substance and drug product manufacture
• A minimum of five (5) years in roles of increasing responsibility in a biopharmaceutical environment; a minimum of two (2) years managing drug substance/drug product facilities; commercial experience optimal
• Experience interacting with FDA, EMA, and other global health authorities
• 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

Responsibilities

• Conduct routine lot disposition activities for finished drug products by ensuring all relevant documentation associated with a lot are accounted for, complete and approved under cGMP standards
• Works collaboratively within CMC Quality and cross-functional stakeholders to ensure deliverables are met to support disposition timelines
• Responsible for compilation and review of batch release documentation packages; shares with external stakeholders (QP)
• Meet with stakeholders and management to communicate lot disposition status; monitor progress and escalate any issues or delays
• Establish, maintain, and report Metrics and Key Performance Indicators for disposition and batch review
• Drive continuous improvement of the QA processes, identifying opportunities and leading them to implementation
• Create and revise relevant Standard Operating Procedures (SOP) and/or Work Instructions (WI)
• Perform additional quality-related duties as assigned by Senior Director, CMC and Quality Distribution

Benefits

• Remote location
• Domestic travel may be required (up to 10%) including required quarterly onsite meetings
• Salary range for posting $170,000 — $180,000 USD
• Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience
• Equity and other forms of compensation may be provided as part of a total compensation package
• Full range of medical, dental, vision, 401k, and other benefits
• Unlimited paid time off
• Parental leave