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QA Regulatory Data SME at Guidehouse - ApplyBlast

QA Regulatory Data SME

Guidehouse

3 months ago

3.2 on Glassdoor

Hybrid

Full Time

Senior

0 applicants

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About this role

This role involves performing an internal audit of drug quality sampling and testing databases to ensure data integrity, regulatory compliance, and methodological consistency for a pharmaceutical client. The specialist will assess data quality against FDA standards, identify deviations, and provide actionable recommendations to strengthen regulatory decision-making processes. The position requires presenting findings to cross-functional leadership teams and supporting the implementation of process improvements.

Responsibilities

Perform comprehensive reviews of database records for accuracy and completeness
Assess compliance of documentation with FDA regulations and SOPs
Identify deviations and risks impacting regulatory decisions
Prepare comprehensive final audit reports detailing observations and root causes
Present findings and recommendations to regulatory and scientific leadership

Skills

Qualifications

Bachelor's Degree in Chemistry or Pharmaceutical Sciences5 Years Experience in Regulatory Data AnalysisAbility to Obtain Public Trust ClearanceMaster's Degree in Regulatory Science (Nice to have)Experience with LIMS Systems (Nice to have)

About Guidehouse

guidehouse.com

Headquarters

Mclean, Virginia, United States

Company Size

10001+ employees

Founded

2018

View Profile

Guidehouse is a leading advisory firm that specializes in integrating commercial and public sector solutions to tackle complex challenges faced by clients. As a unique scaled advisory organization, it leverages insights from both government and commercial perspectives within its various industry segments. Guidehouse provides a range of technology and managed services, focusing on key sectors such as healthcare, financial services, defense, and infrastructure. The firm is recognized for its innovative approach to problem-solving, which combines strategic expertise with practical implementation.