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Job Description - Manager/Senior Manager, Clinical Quality Assurance
Description: We are looking for a motivated individual with the professionalism and sensitivity to successfully interact with diverse individuals. Responsible for assuring those clinical research activities undertaken by OXiGENE in the region responsible are conducted in compliance with all applicable Regulatory and contractual requirements. Management of the activities of internal and/or external auditors within the GCP-QA area. Development and provision of input into functional processes for area managed in support of strategic goals. Serving as a high level technical contributor within the GCP-QA area.
Specific duties include:
Defines schedules and work plans for selecting, monitoring, and overseeing audit activities that are consistent with overall audit strategy and company goals.
Directs GCP-QA audit activities to deliver timely feedback to Senior Management to enable achievement of Company strategic objectives and goals across functional areas within Global development project teams and across commercial functions within the business.
Delegates tasks and allocates resources within work plans and provides GCP-QA direction to internal auditors and/or external contractors/vendors
Contributes to developing and applying new approaches for audit tracking and trending to enable (or provide) feedback into the Quality System
Contributes to the modification, development and implementation of company practices and policies for GCP-QA
Supports the regulatory inspection activities
Establishes a network of relationships with key international Quality Assurance professionals
Directs identification of compliance issues through the use of internal and external audit programs that minimize regulatory and business risk
Provides broad scientific leadership and advice to Global Development personnel related to a specific area |
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