GLP Auditor
sanofi-aventis
Bridgewater, NJ

Commitment is our Strength.
Ready to grow together?

* Driving back disease
* Enhancing the quality of life
* Producing globally, for the greatest number

Let more people feel the impact of your work with sanofi-aventis. World-class research capabilities allow our talented teams to develop medicines that fight challenging diseases in major therapeutic areas. Each year, we invest billions to provide our research and development personnel with the advanced resources and technology to push the limits of science. Sanofi-aventis also supports innovation with research grants to scientists and clinicians throughout the world. Ours is the third-leading pharmaceutical group in the world, and we are proud that our research and development organization ranks among the very best. We employ about 16,000 scientific personnel in 20 research centers on three continents, including approximately 2,600 at our Bridgewater, NJ site. Are you prepared to help us drive back disease?

We currently seek an experienced QA professional to ensure compliance with applicable GLP regulations, SOPs, and sanofi-aventis policies.

RESPONSIBILITIES
* Participate in audits of non-clinical safety and pharmacokinetic studies, systems, facilities, Contract Research Organizations, and vendors/suppliers
* Provide timely and accurate reporting of audit findings.
* Assure corrective action activities are completed and participate in training of operational personnel.
* Provide regulatory guidance to internal and external customers.
* Participate in inspections by Regulatory Authorities.
* Schedule/perform audits of all the various phases of non-clinical studies.
* Determine compliance with applicable GLP regulations, SOPs, study plans, and associated guidelines.
* Summarize and report findings.
* Assist the Q&C GLP Manager during FDA regulatory site visits/inspections.
* Participate in team projects for the validation of computerized systems and/or equipment and collaborate with site Q&C GLP manager to identify issues.
* Ensure computer systems do not adversely impact the conduct of non-clinical studies and also satisfy the demands of regulatory agencies and sanofi-aventis policies and procedures.
* Review SOPs for departments operating under, or supporting, GLPs.

REQUIRED
* B.S/B.A degree in a scientific or related discipline or equivalent technical experience
* 3+ years experience in a GLP environment or 2 years experience in a GLP Quality Assurance Unit
* General knowledge of sanofi-aventis policies, procedures and directives as well as US and international regulations and guidelines associated with preclinical pharmaceutical regulatory issues to ensure compliance with regulatory needs
* Knowledge of GLPs and associated regulations
* Ability to identify deviations from GLP regulations, study plans, and applicable departmental SOPs
* Ability to see overall consequences of regulatory deviations

For more information and to explore available career opportunities, please visit us online at: www.careers.sanofi-aventis.us
Req#: S&MA 9864

Sanofi-aventis is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi-aventis is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants as well as its employees.