Director, Packaging & Distribution QA

The Role:
Immunovant is seeking a Director, Packaging and Distribution Quality with experience in clinical and commercial packaging, labeling, and distribution (domestic and globally). This individual will work closely with our Contract Development and Manufacturing Organizations (CDMOs) and internal CMC Supply Chain team to oversee and manage the distribution of investigational materials for our ongoing clinical trials.

This position will contribute to Immunovant’s success by overseeing the packaging and distribution of clinical materials under the guidance of the Sr. Director, CMC & Distribution Quality, while working closely with internal functions at Immunovant and external strategic partners.

The Director, Packaging and Distribution Quality will provide oversight and direction for Immunovant’s supply chain 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. This candidate will also need to demonstrate the ability to support strategic plans for pack/label activities across multiple clinical programs, establish and maintain Quality Agreements, support deviations and CAPAs, manage complex change controls, and identify and mitigate inspection risks. In addition, this individual provides expertise to partner both internally and externally to drive continuous process improvement and mitigation activities pertaining to the distribution 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:

• Provides Quality oversight/support for pack/label activities across multiple clinical programs
• Perform thorough review and approval of batch production records and creation of batch disposition packets.
• Support the review of clinical and commercial label text, label proofs, and label specifications
• Reviews and approves deviations at CDMOs to assess product quality impact. Monitor effectiveness checks of CAPAs
• Assess product complaints and counterfeit claims
• Perform assessments for change controls and performs final Quality approval
• Supports the generation of risk assessments for distribution and packaging/labeling processes
• Supports shipping qualification/validation studies
• Supports the review of distribution protocols for Contract Distributors
• Contribute to regulatory filing content related to combination products (IND, NDA, etc.)
• May assist in the auditing of contract packaging / labeling sites and distribution centers.
• Effectively communicate ideas, project goals, and results to team members across functions and departments
• May include oversight and mentoring of quality associates, fostering a collaborative and innovative working environment
• Perform additional quality-related duties as assigned by Senior Director, CMC and Quality Distribution

Requirements:

• Bachelor (B.S.) or advanced degree; preferably in Biology, Chemistry, Engineering, or related fields
• A minimum of eight (8) years of GMP experience with a focus on Quality Assurance (QA)
• A minimum of five (5) years in roles of increasing responsibility in a biopharmaceutical environment
• 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 and international travel may be required (up to 10%) including required quarterly onsite meetings