Director,Quality Assurance and Regulatory Affairs

Director, Quality Assurance and Regulatory Affairs

Department:  Quality Assurance

 

Position Summary

 

Ensures compliance with Standard Operating Procedures (SOP’s), FDA regulations and any other regulatory agencies. This position is responsible for overseeing Phase 1 operations, Clinical Trials and Data Management activities as well as Corporate. This position  is also responsible for providing direction to The Clients Institutional Review Board and overseeing all regulatory training aspects for the organization.

 

Essential Responsibilities

 

· Will lead and direct the Quality Assurance Department for multiple facilities.

· Responsible for reviewing the activities of the Quality Assurance department to ensure that appropriate quality reviews are conducted for all areas.

· Ensures The Clients SOPs are written in accordance with current regulatory requirements. This also includes ensuring that critical areas of operations have adequate SOPs in existence to cover The Client from a regulatory standpoint.

· Provides support during any regulatory inspections such as FDA.

· Oversees SOP training, Good Clinical Practices (GCP’s) training and any other training related to FDA, and other regulatory standards.

· Responsible for ensuring training files are in accordance with any regulatory standards.

· Provides oversight to the Clients Institutional Review Board  for pending and ongoing trials as necessary.

· Oversees Report Writers to ensure that Reports are written in accordance with current regulatory standards.

· Other duties as assigned.

 

Qualifications

 

· Bachelors Degree in a scientific  discipline or equivalent experience, masters degree preferred.

· Extensive knowledge of GCP, ICH, FDA guidelines as well as other applicable regulatory requirements.

· 8- 10 years regulatory experience, GCP experience in clinical research preferred.

· At least 5 years managerial experience

· Ability to travel.

· Flexible hours including weekend and evening work.

· Knowledge of Spreadsheet software; Internet software; Project Management software; Database Software; and Word Processing Software.

 

Licensing/Certification Requirements

Certified Quality Manager helpful.