Associate Director/Director, Clinical Quality Assurance

Job Description
Applicants must meet the following requirements:

Bachelor of Science degree in a life science.

Minimum of 10 years relevant experience in pharmaceutical GCP, with at least 3 years in the biotech industry; advanced degree with relevant experience preferred.

Experience with oncology clinical trials is required, international clinical trial experience is a plus.

In-depth knowledge and application of GCP regulations, guidelines and industry practices and the ability to interpret the regulations/guidelines from a quality risk management perspective.

Must be able to handle multiple priorities at once and be willing to travel.

Must be able to work independently with minimal supervision.

The selected candidate will be responsible for:

Advancing the development of the GCP infrastructure within the Clinical Development departments.

Managing the development and execution of the clinical audit plan through selection of technically qualified CQA auditors.

Providing CQA regulatory compliance peer review of critical clinical documents (Protocols, ICD, CSR).

Providing QA oversight of Clinical Development computer system validations and change control.

Providing GCP regulatory guidance to the Clinical Development departments.

Leading the continuous improvement Clinical Organizational Effectiveness (CORE) team.

Conducting GCP training for the company and its contractors.

Preparing annual CQA budget and actively participating in the re-forecasting process.


MacroGenics Inc.

Job Code

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