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Associate Director, CMC Quality Assurance
ImmunovantAssociate Director, CMC Quality Assurance ensuring quality compliance in drug manufacturing at Immunovant. Overseeing quality assurance activities and regulatory compliance to support sterile drug product manufacture.
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Comp & perks- 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
ATS Keywords
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Hard Skills & Tools
Good Manufacturing PracticesQuality AssuranceRegulatory FilingsProcess Control StrategyData IntegrityBatch DispositionSOP DevelopmentQuality Management SystemsClinical Trials OversightOperational Efficiency
Soft Skills
Strong Communication Skills