Associate Director QA, GMP External Operations

Job Description

General/Position Summary:

The Associate Director, Quality Assurance GMP Operations provides end-to-end QA oversight of external manufacturing operations across CDMOs, from process development and technology transfer through manufacturing readiness, ramp-up, and routine clinical and commercial execution. The role ensures compliant and reliable operations, effective Quality risk management, and strong internal and external partnerships to support product quality and supply.

The role partners closely with internal technical, manufacturing, supply chain, regulatory, and Quality functions, as well as external CDMO Quality and Operations teams, to establish robust and sustainable operations, enable successful transfer and scale-up, resolve operational Quality issues, and maintain a state of compliance throughout the product lifecycle.  A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders for advancing quality outcomes and operational excellence.

**

Key Duties & Responsibilities:**

Leadership & Quality Strategy

·     Provide Quality leadership and strategic direction across development, technology transfer, launch, and commercial manufacturing.

·     Establish the QA oversight model, governance, escalation pathways, and performance expectations.

·     Identify and mitigate key Quality and operational risks.

·     Advance digitization and technology-enabled solutions to improve QA oversight, efficiency, and decision making.

QA Operational Oversight

·     Provide end-to-end QA oversight from process development and technology transfer through baseline operations, ramp-up, and routine manufacturing execution.

·     Ensure manufacturing and product disposition activities meet regulatory and GMP requirements.

·     Provide Quality leadership for operational issues impacting manufacturing, product quality, or supply.

·     Partner cross-functionally to enable compliant and reliable execution.

QMS & Compliance

·     Ensure compliance with applicable GMP ...

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis.