Sr. Quality Management Systems Specialist
BioCryst Pharmaceuticals, Inc.
August 20, 2026
Remote friendly (North Carolina, United States)
United States
Operations
Sr. Quality Management Systems Specialist
Responsibilities
- Administer the Document Control/eDMS/QMS to ensure compliance with BioCryst SOPs, Quality Systems, applicable cGMPs, and regulatory requirements.
- Serve as Document Control/eDMS/QMS administrator; manage user accounts and training/support for Veeva eDMS/QMS.
- Support review/update/filing/distribution and life cycle/retention of controlled documents (SOPs, methods, protocols, reports, technical documents); maintain templates, master content lists, tracking sheets, and electronic filing systems.
- Coordinate approval processes and upload/filing to systems (Veeva, ComplianceWire, SharePoint as applicable); assist with Document Biennial Review; perform proofreading/editing/word processing.
- Assist with GxP Training Program administration (ComplianceWire LMS): user setup, training file reviews, curriculum updates, training assignments/tracking, backup Organization Administrator, support for Content Administrators and eDMS/QMS sessions.
- Support Vendor Management Program: maintain assessment trackers, shepherd vendor assessments, support change control for vendor requests/assessments, ensure completeness, distribute documents for internal review, maintain vendor-related filing, and support validation/implementation and cross-functional QA support.
Qualifications
- Bachelor’s preferred; or Associate degree + 5 years pharma QA Ops/Manufacturing/QC or related experience (or equivalent).
- Strong computer/web skills (Word, Excel, PowerPoint, OneDrive, SharePoint); Veeva experience desired.
- Results-oriented, strong analytical/problem-solving, organization and attention to detail; ability to manage multiple projects with minimal oversight.
- Confidentiality with sensitive documents; adapt to changing priorities.
- Knowledge of FDA electronic records guidance (21 CFR Part 11) and US FDA GMP requirements.
- Ethical conduct and ownership.
Responsibilities
- Administer the Document Control/eDMS/QMS to ensure compliance with BioCryst SOPs, Quality Systems, applicable cGMPs, and regulatory requirements.
- Serve as Document Control/eDMS/QMS administrator; manage user accounts and training/support for Veeva eDMS/QMS.
- Support review/update/filing/distribution and life cycle/retention of controlled documents (SOPs, methods, protocols, reports, technical documents); maintain templates, master content lists, tracking sheets, and electronic filing systems.
- Coordinate approval processes and upload/filing to systems (Veeva, ComplianceWire, SharePoint as applicable); assist with Document Biennial Review; perform proofreading/editing/word processing.
- Assist with GxP Training Program administration (ComplianceWire LMS): user setup, training file reviews, curriculum updates, training assignments/tracking, backup Organization Administrator, support for Content Administrators and eDMS/QMS sessions.
- Support Vendor Management Program: maintain assessment trackers, shepherd vendor assessments, support change control for vendor requests/assessments, ensure completeness, distribute documents for internal review, maintain vendor-related filing, and support validation/implementation and cross-functional QA support.
Qualifications
- Bachelor’s preferred; or Associate degree + 5 years pharma QA Ops/Manufacturing/QC or related experience (or equivalent).
- Strong computer/web skills (Word, Excel, PowerPoint, OneDrive, SharePoint); Veeva experience desired.
- Results-oriented, strong analytical/problem-solving, organization and attention to detail; ability to manage multiple projects with minimal oversight.
- Confidentiality with sensitive documents; adapt to changing priorities.
- Knowledge of FDA electronic records guidance (21 CFR Part 11) and US FDA GMP requirements.
- Ethical conduct and ownership.