Senior QMS & Document Control Leader

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 70,000 - 110,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Quality Management Systems Specialist to maintain the BioCryst Document Control System in compliance with SOPs, Quality Systems, cGMPs, and Regulatory requirements.

You will support the Vendor Qualification, oversight, and management process and assist with daily vendor-related tasks in line with BioCryst SOPs and Regulatory standards. The role involves administering eDMS/QMS, training program support, records retention, and collaboration across QA

Qualifications

• Bachelor’s degree preferred or equivalent with 5 years pharma QA/operations experience.
• Strong technical skills with Word/Excel/PowerPoint/SharePoint/OneDrive.
• Knowledge of FDA regulations and 21 CFR Part 11.
• Ability to manage multiple projects with minimal oversight.
• Ethical conduct, ownership and accountability.

Responsibilities

• Administer Quality Management Systems to ensure CGMP regulatory compliance.
• Serve as Document Control/eDMS/QMS administrator and manage access.
• Assist with reviewing, updating, filing and distribution of controlled documents.
• Create and maintain electronic filing systems and templates.
• Support vendor qualification documentation and lifecycle processes.
• Assist with training programs and ComplianceWire LMS administration.

Skills

QA Operations

Quality Control

Regulatory compliance

Documentation management

Analytical skills

Education

Bachelor's degree or equivalent

Associate degree or equivalent

Tools

Microsoft Word

Excel

PowerPoint

OneDrive

SharePoint

Veeva

Job description

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Quality Management Systems Specialist to maintain the BioCryst Document Control System in compliance with SOPs, Quality Systems, cGMPs, and Regulatory requirements.

You will support the Vendor Qualification, oversight, and management process and assist with daily vendor-related tasks in line with BioCryst SOPs and Regulatory standards. The role involves administering eDMS/QMS, training program support, records retention, and collaboration across QA