Associate Director, CMC Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver robust technical leadership in alignment with global Good Manufacturing Practices (GMPs) regulations and guidelines.

• Offer independent oversight and compliance guidance with authority for CMC Quality and product disposition, encompassing CDMO’s, CMOs, and Packaging Facilities.

• Enhance process and product quality through effective CMC quality systems, ensuring sufficient supplier oversight and surveillance.

• Authorize Protocols and Reports, Master Batch Records, and Executed Batch Records for Drug Product manufacturing, including sterile combination product filling and packaging.

• Assist in the development and execution of the Process Control Strategy.

• Evaluate and verify process data to ensure adherence to data integrity and traceability regulatory requirements where applicable.

• Disposition batches for human use in Clinical Trials.

• Facilitate health authority inspection readiness activities for Immunovant and its partners; support health authority audits conducted by regulatory agencies.

• Aid in the preparation and review of regulatory submissions and safety data (e.g., INDs, BLAs, Annual Reports) to guarantee compliance with regulatory procedures.

• Contribute to the development and maintenance of internal manufacturing and operational SOPs related to GxP activities, with a primary focus on cGMP regulations and sterile materials.

• Confirm that all products manufactured comply with registration and cGMP standards based on global regulatory requirements.

• Assist in identifying and implementing efficiencies across the manufacturing process, including process development, device development, and sterile drug product manufacturing (filling, labeling, packaging, and distribution).

• Utilize GMP-regulated quality management systems and eQMS to manage document control, change control, deviations/complaints, DS/DP release, and CAPAs.

• Undertake additional quality-related tasks in support of the QLT as required.

⛳️ Requirements

• Bachelor’s or master’s degree in Biology, Chemistry, Engineering, or related disciplines.

• At least five (5) years of GMP experience focusing on Quality Assurance (QA) with significant operational experience in sterile drug product manufacturing; with a minimum of two (2) years managing sterile drug product/sterile drug product facilities.

• Excellent communication abilities: oral, written, and listening skills.

• Experience engaging with FDA and international regulatory bodies/health authorities; pre-approval readiness (PAI) for commercial manufacturing.

• Strongly preferred experience in medical devices, combination products, and commercial biologics.

• Experience with clinical or commercial distribution processes is an added advantage.

🏝️ Benefits

• Equity and other compensation forms may be included as part of the total compensation package.

• Comprehensive medical, dental, vision, 401k, and additional benefits.

• Unlimited paid time off.

• Parental leave.