Associate Director, CMC Quality Assurance
Salary range
$175,000–$195,000/yrBenefits
Unlimited PTO
Similar Jobs
See allAuditor I, Clinical Quality Assurance
Iovance Biotherapeutics
Global
GCP
GMP
Regulatory Compliance
Associate Director, Technical Operations CMC Strategy
Travere Therapeutics
US
Regulatory Submissions
Associate Director/Director Drug Product, CMC
Dianthus Therapeutics
US
Regulatory Submissions
Director, Quality Systems & Regulatory Affairs
CEFALY Technology
US
Quality Management
Regulatory Affairs
Executive Director, Regulatory Affairs
Kyverna
US
Regulatory Affairs
Cell Therapy
FDA Regulations
Key Responsibilities:
- Provide strong technical leadership in support of activities governed by global GMP regulations and guidelines.
- Provide independent oversight and compliance direction for CMC Quality and product disposition, including CDMOs and CMOs.
- Support process and product quality through effective CMC quality systems and supplier oversight.
Qualifications and Requirements:
- Bachelor’s or master’s degree in Biology, Chemistry, Engineering, or related fields.
- Minimum 5 years of GMP experience with focus on QA, including 2 years managing sterile drug product facilities.
- Experience interacting with FDA and global health authorities, plus pre-approval readiness for commercial manufacturing.
Work Environment and Compensation:
- Remote location with a dynamic, fast-paced, entrepreneurial environment.
- Salary range $175,000 - $195,000 USD based on experience and location.
- Full benefits package including unlimited PTO and parental leave, plus equity opportunities.
Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.