Compliance Manager
: Job Details :

SATHRAM CORPORATION has openings for the position Compliance Manager with Master's degree in Engg (any), Buss Admin, Life Sci, or related scientific/quantitative discipline or related and 1 yrs of exp to create innovative and integrated programs, aligning with overall business strategies. Implement FDA-regulated biotechnology or drug development requirements including, FDA 21 CFR Parts 11, 820, GCP, ICH, HIPPA, and CDISC standards. Provide expert guidance and direction of the Quality Systems to a team of Quality specialists responsible for developing, establishing, and maintaining quality systems programs, processes, procedures, training materials, and controls enhancing, the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations/audits including cGMP, GCP, ICH compliance, clinical, and other activities. Review new and revised regulations/standards/guidelines, determining and interpreting content and implications with business partners to assess the impact on clinical trial conduct and associated processes. Drive discussions with business partners during procedural or process changes to ensure regulatory requirements are understood and maintained.Work location is Plainsboro,NJ with required to travel and work from various unanticipated client worksites throughout the USA.Please mail resumes to 666 Plainsboro Road,Suite 1236,Plainsboro,NJ 08536 (OR) e-mail : ...@sathramcorp.com