Associate Director, CMC QA

The Role:
Immunovant is seeking an Associate Director, CMC Quality Assurance - Lot Disposition to coordinate and oversee the disposition of clinical drug products at a rapidly growing biotechnology company. This individual will play a key role in building collaborative working relationships with internal and external partners to coordinate the various elements necessary to execute the disposition and remove barriers to ensure a reliable supply of medicines. Additionally, this individual will work closely with our internal partners to ensure right product / right country and escalate to Quality Management of issues delaying or preventing release.

This position will contribute to Immunovant’s success by conducting the final disposition of finished drug products under the guidance of the Sr. Director, CMC & Distribution Quality, while working closely with internal functions at Immunovant and external strategic partners.

The Associate Director, CMC Quality Assurance - Lot Disposition will provide oversight and direction for Immunovant’s lot disposition operations to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate. This position will apply knowledge of global regulations to assist in the creation and approval of clinical packaging and labeling materials. In addition, this individual provides expertise to partners both internally and externally to drive continuous process improvement and mitigation activities pertaining to the disposition of investigational materials for clinical trials. This individual will perform all of these activities all while ensuring a culture of quality and compliance through effective leadership and strong adherence to Immunovant core values.

Key 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

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

Work Environment:

• Remote location
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic travel may be required (up to 10%) including required quarterly onsite meetings