Senior Quality Management Systems Specialist

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Manage the BioCryst Document Control System in alignment with company SOPs, Quality Systems, relevant cGMPs, and regulatory standards.

• Act as the Document Control/eDMS/QMS administrator.

• Facilitate the creation of new user accounts, provide training, and support for Veeva eDMS/QMS.

• Examine, revise, archive, disseminate, and oversee controlled documents and templates.

• Organize the approval, upload, and filing of controlled documents in Veeva, ComplianceWire, and SharePoint.

• Assist in managing document life-cycle, retention, biennial reviews, retrieval, and archiving processes.

• Maintain Master Content Lists and tracking sheets for quality documents.

• Aid in the preparation of quality metrics for presentations to QA management.

• Oversee and support the GxP Training Program and ComplianceWire Learning Management System (LMS).

• Assign and monitor employee training while maintaining electronic training records.

• Support the training of departmental ComplianceWire Content Administrators.

• Administer the Vendor Management Program, including assessments, trackers, change controls, and vendor qualification documentation.

• Review vendor assessment documents for completeness and coordinate timely distribution and internal review.

• Maintain electronic vendor folders and related assessment records.

• Assist in validation and implementation processes for Quality Systems.

• Provide cross-functional support within the QA department.

• Manage versions of presentations, meeting minutes, and action items for important business meetings.

• Conduct proofreading, editing, word processing, and filing tasks.

• Undertake additional duties as assigned.

⛳️ Requirements

• A Bachelor’s degree is preferred; alternatively, an Associate Degree or equivalent coupled with five (5) years of pharmaceutical experience in QA Operations, Manufacturing, QC, or other relevant areas is required, or a suitable combination of education and experience.

• Strong technical computer skills are essential.

• Proficiency in Microsoft Word, Excel, PowerPoint, OneDrive, and SharePoint is required.

• Experience with any Veeva environment is highly desirable.

• Familiarity with FDA regulations and industry standard guidelines for electronic records, such as 21 CFR Part 11, is necessary.

• Knowledge of US FDA GMP requirements and associated guidelines is important.

• Strong analytical and problem-solving skills are required.

• Excellent organizational skills and attention to detail are essential.

• Ability to manage and complete multiple projects with minimal supervision is crucial.

• Ability to thrive in a fast-paced, team-oriented environment is necessary.

• Capacity to maintain confidentiality and handle sensitive documents effectively is required.

• Ability to adapt to shifting priorities efficiently is essential.

• Demonstrated ethical conduct, accountability for actions, and focus on goals are necessary attributes.

🏝️ Benefits

• Equal opportunity employer.

• Commitment to providing equal employment opportunities without regard to protected characteristics.

• Culture of engagement and accountability.

• Rewards for innovative thinking and achievement of key objectives.

• Opportunities for professional and personal growth.

• People-first culture.

• Employee input into company goals and business objectives.