BioCryst Pharmaceuticals, Inc. · 4 hours ago
Sr. Quality Management Systems Specialist
United States
Full-time
Remote
Senior Level
5+ years expBioCryst Pharmaceuticals, Inc. is dedicated to improving the lives of individuals with rare diseases through innovative medicines. The Sr. Quality Management Systems Specialist is responsible for maintaining compliance with quality management systems and supporting vendor qualification processes, ensuring adherence to regulatory requirements and internal procedures.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Works to administer effective Quality Management Systems ensuring compliance to applicable internal procedures, cGMPs, and regulatory requirements, as follows:
Serves as Document Control/eDMS/QMS administrator
Assists with provision of new user accounts, training, and support for Veeva eDMS/QMS
Supports the review, update, filing and distribution of controlled documents, including standard operating procedures, standard test methods, protocols, summary reports, and technical documents according to specific Document Control format standards and guidelines
Creates and maintains controlled document templates
Ensures controlled documents conform with applicable procedures and are maintained to latest revisions; reviews formats for consistency
Responsible for timely distribution of draft and final controlled documents
Coordinates the approval process and orderly upload and filing of controlled documents to Veeva, ComplianceWire, and SharePoint, as applicable
Supports controlled document life cycle/retention procedures
Assists with Document Biennial Review Program
Performs proofreading, editing, word processing, and filing of controlled documents
Creates and maintains electronic filing systems for controlled documents
Maintains Master Content Lists and Tracking Sheets for SOPs, Policies, Work Instructions, Test Methods, Forms, and Templates
Assists with the preparation of quality metrics for QA for presentation to management
Assists with records retention and archiving, ensuring adherence to specific records retention schedules
Assists with document retrieval for internal audits and regulatory inspections
Supports the administration of the GxP Training Program as follows:
Assists with provision of new user accounts, training , and support for ComplianceWire LMS
Assists with employee Training Program and periodic review of all training files
Assists with Training Curriculum updates for all employees, and maintenance of employee electronic training files
Collaborates with internal departments to identify training needs; assigns and tracks training
Back-up ComplianceWire Organization Administrator
Supports training of internal departmental ComplianceWire Content Administrators
Assists with eDMS/QMS training sessions
Supports the administration of the Vendor Management Program as follows:
Reviews the GxP assessment schedules and communicates with internal customers in a timely manner to prepare for routine vendor reassessments
Maintains GxP tracker and Assessment Status tracker spreadsheets and shepherds assessments through the process according to priority and the assessment schedule
Supports change control processes related to vendor management (i.e., New Vendor Requests, Changes to Existing Vendor Requests, Vendor Re-Assessment, Vendor Risk Assessment, Vendor Summary, etc.)
Reviews documentation/information requirements to ensure completeness prior to finalization and closure of assessment
Responsible for timely distribution of vendor assessment documents for internal review upon completion by the vendor
Supports/provides input into vendor management-controlled documents and life cycle/retention procedures
Performs proofreading, editing, word processing, and filing to support Quality Assurance Documentation used for vendor qualification/management
Creates and maintains filing systems for all vendor-related assessment documents and information
Maintains vendor-related documentation in electronic vendor folders
Supports the FAR and/or other Stakeholders as needed in completing vendor qualification documentation
Facilitates timely review and discussion with internal vendor documentation reviewers as needed to resolve comments/questions
Supports validation and implementation processes for Quality Systems
Provides cross-functional support within QA department, as needed
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
Maintains an awareness of evolving industry standards for document generation and electronic document management
Support critical business meetings by managing presentation versions, meeting minutes, and action items
Other duties as assigned
Qualification
Required
Bachelor's degree preferred, or Associate Degree or equivalent plus five (5) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required, or an equivalent combination of education and experience
Possess strong technical computer skills with proficiency in using various computer programs and web-based applications, including Microsoft Word, Excel, PowerPoint, One Drive, SharePoint
Results-oriented, with a strong work ethic and ability to manage and complete multiple projects with minimal oversight
Strong analytical and problem-solving skills
Strong organizational skills and attention to detail
Ability to work successfully in a fast-paced, team-oriented environment
Ability to maintain confidentiality and work with sensitive documents
Adapts to changing priorities effectively
Knowledge of FDA regulations and industry standard guidelines for electronic records; i.e., 21 CFR Part 11
Demonstrate ethical conduct, focus on goals, take ownership of actions, and act in the best interest of the Company
Knowledge of US FDA GMP requirements and associated guidelines
Preferred
Experience with any Veeva environment is desired
Company
BioCryst Pharmaceuticals, Inc.
BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases.
501-1000 employees
H1B Sponsorship
BioCryst Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.76BKey Investors
MidCap FinancialNational Institute of Allergy and Infectious Diseases
2023-04-17Post Ipo Debt· $450M
2021-11-22Post Ipo Equity· $350M
2020-12-07Post Ipo Debt· $325M
Leadership Team
Charlie Gayer
President and Chief Commercial Officer
Nancy Hutson
Chair
Recent News
2026-01-22
Company data provided by crunchbase