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Description
Business Title Manager, Computer Systems Quality
Requisition ID 31631BR
Job Category Quality
Locations USA - Princeton, NJ
Shift 1
Job Posting Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
Manage all of the activities required to conduct external and internal computer compliance audits.
Provide Quality and Regulatory input and support to the various project teams regarding the development, testing, and release of computerized systems to external and internal clients.
Act as the key contact for resolving regulatory issues identified in the development, testing and utilization of computer systems.
Provide specialized validation auditing services to internal and external clients.
Education/Qualifications Minimum Required:
BA or BS Degree required preferably in Life Science, Computer Science/Technology, Quality or relevant industry experience
Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Preferred
Advanced degree or equivalent experience
Knowledge of the drug development process from the perspective of a contract research organization
Experience Minimum Required:
Minimum 5 Years of experience in computer systems validation or related industry experience
Minimum 3 years experience in a regulated industry
Minimum 2 years of Supervisory / Management experience
Computer technology experience
Strong analytical, organizational and problem solving/logic skills
Working knowledge of Software Development methodologies
Demonstrated ability to handle multiple competing priorities across clinical operating units
Ability to function as a member of a global clinical team
Strong interpersonal and communication skills.
Details:
Job Id:
33397105
Posted / Updated:
2/8/2012 4:15:28 AM
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