Compliance Manager

4 weeks ago


Plainsboro, New Jersey, United States Sathram Corporation Full time
Job Title: Compliance Manager

About the Role:

Sathram Corporation is seeking a highly skilled Compliance Manager to join our team. As a Compliance Manager, you will be responsible for implementing and maintaining FDA-regulated biotechnology or drug development requirements, including FDA 21 CFR Parts 11, 820, GCP, ICH, HIPPA, and CDISC standards.

Key Responsibilities:

* Implement and maintain quality systems programs, processes, procedures, training materials, and controls to enhance the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations/audits.

* 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.

Requirements:

* Master's degree in Engg (any), Buss Admin, Life Sci, or related scientific/quantitative discipline or related.

* 1 year of experience in a related field.

Work Location:

Plainsboro, NJ. Travel required to various client worksites throughout the USA.

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