Senior Quality Systems & Document Control Lead

BioCryst Pharmaceuticals, Inc.; Northern (KY); Hybrid; 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 SOPs, cGMPs and regulatory requirements, and to support the Training Program and Vendor Qualification processes.

The role involves administering eDMS/QMS tools (Veeva), preparing metrics, assisting with audits, and ensuring timely filing and retention. Ideal candidate holds a BS or equivalent with Pharma QA experience and strong attention to detail.

Qualifications

• Bachelor's degree preferred or equivalent with pharma QA experience.
• Experience with regulatory compliance and cGMP requirements.

Responsibilities

• Administer Document Control/eDMS/QMS; manage templates and revisions.
• Support training program administration and vendor qualification.
• Assist with audits and regulatory inspections; maintain filing systems.

Skills

MS Word

MS Excel

MS PowerPoint

SharePoint

Veeva eDMS/QMS

Quality documentation

Regulatory compliance

Attention to detail

Education

Bachelor's degree or equivalent

Tools

Veeva eDMS/QMS

ComplianceWire

SharePoint

Job description

BioCryst Pharmaceuticals, Inc. is seeking a Sr. Quality Management Systems Specialist to maintain the Document Control System in compliance with SOPs, cGMPs and regulatory requirements, and to support the Training Program and Vendor Qualification processes.

The role involves administering eDMS/QMS tools (Veeva), preparing metrics, assisting with audits, and ensuring timely filing and retention. Ideal candidate holds a BS or equivalent with Pharma QA experience and strong attention to detail.