Founded in 2018, Immunovant is a clinical-stage biopharmaceutical company that strives to help patients with autoimmune diseases lead "normal lives." As an empl
Associate Director, CMC Quality Assurance
Location
United States
Posted
1 day ago
Salary
$175K - $195K / year
Seniority
Senior
Job Description
Associate Director, CMC Quality Assurance
Immunovant
• Provide strong technical leadership in support of activities governed by global Good Manufacturing Practices (GMPs) regulations and guidelines • Provide independent oversight and compliance direction with authority for CMC Quality and product disposition, including CDMO’s, CMOs and Packaging Facilities • Support process and product quality through effective CMC quality systems, ensuring adequate supplier oversight/surveillance • Approve Protocol and Reports, Master Batch Records and Executed Batch Records for Drug Product manufacturing including sterile combination product filling and packaging • Support development and implementation of Process Control Strategy • Review and verify process data to assure compliance with data integrity and traceability regulatory requirements as appropriate • Disposition batches for human use in Clinical Trials • Support health authority inspection readiness activities for Immunovant and its partners ; support health authority audits by regulatory agencies • Assist in preparation and review of regulatory filings and safety data (e.g., INDs, BLAs, Annual Reports) to ensure compliance with regulatory procedures • Assist with development and maintenance of internal manufacturing and operational SOPs related to GxP activities, with primary focus on cGMP regulations and sterile material • Ensure that all products manufactured meet the registration and cGMP requirements based on global regulatory requirements • Support identifying and implementing efficiencies in the overall manufacturing process including process development activities, device development activities, and sterile drug product manufacturing (filling, labeling, packaging, and distribution) • Utilize GMP-regulated quality management systems and eQMS, to complete document control, change control, deviations/complaints, DS/DP release and CAPAs • Perform other quality-related responsibilities in support of the QLT as necessary
Job Requirements
- Bachelor or master’s degree in Biology, Chemistry, Engineering, or related fields
- A minimum of five (5) years of GMP experience with a focus on Quality Assurance (QA) with substantial operational experience in sterile drug product manufacture; in roles of increasing responsibility; a minimum of two (2) years managing sterile drug product/sterile drug product facilities;
- Strong communication skills: oral/written and listening
- Experience interacting with FDA and global regulatory bodies/health authorities; pre-approval readiness (PAI) for commercial manufacturing
- Experience in medical device, combination product and commercial biologics strongly preferred
- Experience with clinical or commercial distribution processes is a bonus.
Benefits
- 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
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