Sr. Quality Management Systems Specialist

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

JOB SUMMARY:

The Sr. Quality Management Systems Specialist is responsible for ensuring the BioCryst Document Control System is maintained in compliance with BioCryst SOPs, Quality Systems, applicable cGMPs, and Regulatory requirements, and for assisting with administration of the BioCryst Training Program.

This position is also responsible for supporting the BioCryst Vendor Qualification, oversight, and management process, and will ensure that daily operational vendor-related tasks are conducted in compliance with BioCryst SOPs, Quality Systems, applicable cGMPs, and Regulatory requirements.

ESSENTIAL DUTIES & 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.

EXPERIENCE & QUALIFICATIONS:

• 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.
• Experience with any Veeva environment is desired.
• 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.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.