You are viewing a preview of this job. Log in or register to view more details about this job.

Senior Regulatory Compliance Specialist (Hybrid Work Environment)

SENIOR REGULATORY COMPLIANCE SPECIALIST (Hybrid Work Environment)
 
General Summary
This is an individual contributor role that focuses on compliance with 21 CFR Part 58 and 21 CFR Part 11. The Senior Regulatory Compliance Specialist is an experienced and self-motivated professional with excellent communication skills and the ability to promote the concepts of quality and integrity and to affect positive change through successful collaboration with all levels of employees within the organization.  This position will be eligible for a flexible work arrangement (up to 50% remote).
 
Key Responsibilities
  • Serve as the quality liaison to the Validation Committee
  • Manage and perform audits of computerized system validation deliverables, including change control and vendor audits
  • Provide regulatory advice to validation project teams
  • Monitor updates to federal and international regulatory requirements
  • Manage, conduct, and provide expertise and consultation for quality system process improvement initiatives
  • Conduct facility and process inspections to assure compliance with Standard Operating Procedures (SOPs) and regulatory requirements
  • Conduct audits of GLP subcontractors and critical vendors
  • Conduct study audits (protocol, in-process, data, report) for a variety of data and study types to assure compliance with regulatory, protocol, and SOP requirements
  • Provide recommendations to management for process improvements
  • Maintain and present timely and accurate metrics for identified quality KPIs
  • Review Standard Operating Procedures for regulatory compliance
  • Develop and present training presentations
  • Perform other duties as required by senior level management

Requirements/Minimum Qualifications
  • A Bachelor Degree
  • Minimum of seven years of GLP experience
  • Applied knowledge of computerized system validation requirements in a GLP environment (21 CFR Part 11)
  • Effective time management techniques are essential to prioritize work flow and meet deadlines
  • Computer skills are essential (MS Office Suite)
  • This position is required to work in an office and laboratory setting. Entry to laboratory environment may require use of PPE depending upon the nature of the scientific project, specific immunizations may be required
  • Domestic travel (less than 20%) will be required
  • As a Federal contractor, Southern Research may be required to comply with a Federal COVID-19 vaccination mandate. In that event, Southern Research will require that all newly hired employees show proof of full COVID vaccination or authorized exemption prior to their start date.

Preferred Qualifications
  • A GLP certification (RQAP-GLP)
  • Knowledge of Six Sigma principles and tools
  • Experience working with cross-functional teams
  • ISO experience
  • Industry leadership (SQA, ASQ, etc.)