Associate Director Of GCP

duties & responsibilities but not limited to the following:

* Assist with development of the audit strategy and programs.
* Assure timely execution of approved audit programs and schedule.
* Provides oversight and directs training of CQA staff in all aspects of the quality management function; especially as it relates to conducting and hosting auditing..
* Identify/monitor GCP compliance risks;provide guidance on mitigation/management of such risks.
* Lead and/or support GCP inspection readiness and inspection management activities.
* Represent CQA in Study Management Team, GCP Compliance Committee, and Clinical Quality System review and improvement teams.
* Monitor and maintain CQA operations within budget.
* Lead and/or participate in GCP site and vendor audits in accordance with the company's standard operating procedures, quality policies and/or plans.
* Interpret policies, standards, and regulations, and applies to evaluation of potentially critical problems Exercises sound and balanced judgment in evaluating compliance of quality systems, processes, procedures, and protocols.
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