Director, Packaging & Distribution QA

Summary

Join Immunovant, a clinical-stage immunology company, as their Director, Packaging and Distribution Quality. You will oversee the packaging and distribution of investigational materials for clinical trials, working closely with CDMOs and internal teams. This role requires experience in clinical and commercial packaging, labeling, and distribution, both domestically and globally. You will ensure compliance with FDA and other global health authority requirements, contribute to regulatory filings, and manage quality agreements. The position offers a remote work environment and a competitive salary and benefits package. You will also support strategic plans for pack/label activities across multiple clinical programs and drive continuous process improvement.

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

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

Benefits

• Remote location
• Salary range for posting $210,000 — $220,000 USD
• 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