Quality Management System Specialist - Remote

Overview

The Quality Management System Specialist at Oak Hill Bio will be responsible for maintaining and overseeing the Quality Management System with a focus on compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

In Short

• Maintain and update QMS documentation in alignment with global GCP and GMP regulations.
• Manage deviation tracking and implement CAPAs.
• Oversee ACE eQMS system documentation.
• Compile annual audit plans for GXP vendors.
• Coordinate internal and external audits.
• Maintain the Approved Vendor List and qualification records.
• Support GCP inspection preparedness activities.
• Deliver training on GCP and quality best practices.
• Prepare metric reports for quality management review meetings.
• Work in a collaborative, mission-driven culture.

Requirements

• Bachelor’s degree in life sciences or a related field.
• 2-5 years’ experience in Quality Assurance in the clinical research or pharmaceutical industry.
• In-depth knowledge of global GCP and/or GMP regulations.
• Strong organizational and communication skills.
• Proven ability to manage multiple projects.
• Attention to detail and meticulous record keeping skills.
• CSV experience and data integrity knowledge is a plus.

Benefits

• Opportunity to make a meaningful impact in scientific innovation.
• Supportive and forward-thinking work environment.
• Collaboration with experienced leaders.