Manager, Information Systems Quality Assurance (ISQA) (2005922)

Position Summary: The primary purpose of this position is to ensure that electronic systems comply with Part 11 regulatory requirements and that associated processes are adequately described and supported by written procedures. This position will manage the quality systems associated with the creation, modification, maintenance, or transmission of electronic records.

Major Job Responsibilities:

35% Manage the validation of regulated electronic systems
5% Assist in the responses to RFPs with regard to electronic systems? quality controls
5% Represent Dendrite during audits performed by our clients 5
10% Participate in the development of system design specifications for new systems
10% Manage, approve, and maintain documentation for change control of electronic systems
5% Audit vendors and business partners
5% Author and revise standard operating procedures (SOPs).
5% Participate in the development and performance of annual internal audit
10% Promote code from development environment to production environment
5% Assist the Director of Validation Services in contracted validation activities performed for clients
5% Provide training to the staff and to our vendors? employees? as needed
Knowledge/Skills required for the Position:
This position must have knowledge and experience in the use of electronic systems for FDA-regulated activities.
Experience within the pharmaceutical industry is required.
Well-developed communication skills, experience in performing validation activities, and the ability to work with moderate supervision.

Education Required:

BA/BS or equivalent experience

Experience Required:

18 mos. - 3 years experience

This position is responsible for quality assurance of regulated electronic systems.

Please apply at our website:

http://hostedjobs.openhire.com/onlinejobs/jobs/submit.cfm?fuseaction=dspjob&jobid=137892&company_id=15614&version=1&jobboardid=24