Sr. Clinical QA Manager
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MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer and other serious, complex diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position:
The Sr. Clinical QA Manager is responsible for providing support in the execution of the Company s audit plans and strategies to ensure overall quality system compliance for Clinical. This role will have a heavy focus on the auditing of investigator sites, vendors and systems.
Responsibilities and Job Duties:
*Execution of MacroGenics, Inc. audit plans/strategies
*Conduct and/or manage investigator site, vendor and system audits of MacroGenics processes
*Assist with the processing and evaluation of audit findings to monitor overall quality system compliance
*Utilize audit outcomes to identify quality related trends and areas of business and/or regulatory risk
*Assist functional areas in developing and implementing processes, procedures, and systems to perform critical activities in compliance with applicable regulations and company standards
*Provide consultation on regulatory compliance issues to MacroGenics project teams
*Develop and conduct training programs in all aspects of GCP
*Perform other Clinical QA duties as necessary