Quality Systems & Documentation Lead (eDMS/Veeva)

BioCryst Pharmaceuticals, Inc.; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Quality Management Systems Specialist to maintain the Document Control System in compliance with BioCryst SOPs, quality systems, cGMPs, and regulatory requirements, and to assist with the Training Program administration.

The role also supports Vendor Qualification and oversight, ensuring daily vendor-related tasks adhere to SOPs and regulatory expectations. A strong background in QA operations and FDA guidance is essential.

Qualifications

• Bachelor’s degree preferred, or Associate Degree or equivalent plus five years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required, or an equivalent combination of education and experience.
• Proficiency with Microsoft Word, Excel, PowerPoint, One Drive, SharePoint.
• Experience with any Veeva environment is desired.
• Results-oriented with the ability to manage and complete multiple projects with minimal oversight.
• Strong analytical and problem-solving skills.
• Knowledge of FDA regulations and 21 CFR Part 11.

Responsibilities

• Administer Document Control/eDMS/QMS per SOPs and regulatory requirements.
• Assist with creation and distribution of controlled documents.
• Maintain document templates and electronic filing systems.
• Coordinate approval and upload of controlled documents to Veeva/SharePoint.
• Support GxP Training Program administration and LMS.
• Assist with vendor management and qualification documentation.
• Support regulatory inspections and internal audits.
• Ensure compliance with safety rules and evolving industry standards.

Skills

Document control

Veeva eDMS

Quality systems

Regulatory compliance

Microsoft Office

Attention to detail

Analytical skills

Education

Bachelor’s degree preferred

Associate degree + 5 years pharma QA

Tools

Veeva

ComplianceWire LMS

SharePoint

OneDrive

Excel

PowerPoint

Job description

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Quality Management Systems Specialist to maintain the Document Control System in compliance with BioCryst SOPs, quality systems, cGMPs, and regulatory requirements, and to assist with the Training Program administration.

The role also supports Vendor Qualification and oversight, ensuring daily vendor-related tasks adhere to SOPs and regulatory expectations. A strong background in QA operations and FDA guidance is essential.