Director, Quality Control Contractor

The Director, Quality Control (contractor) will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinical and commercial development.

Develop and Lead analytical quality control strategy across multiple programs.

Review analytical methods, specifications, and validation activities for adequacy and collaborate on updates, as required.

Support analytical method transfer, as required

Collaborate on supplier qualification and/or remediation activities.

Oversee the stability program design and execution across multiple programs.

Monitor and report on stability trends and product quality attributes as required.

Ensure ongoing regulatory compliance of stability activities.

Manage supplier ongoing relationships.

Perform routine reviews of testing results and overall quality of documentation.

Drive issue resolution to facilitate regulatory compliance.

Provide tactical support for regulatory submissions

Support health authority inspections and audits, as required.

Review analytical and stability sections within CMC filings.