Senior Quality Management Systems Specialist

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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BioCryst Pharmaceuticals, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $450M Post-IPO Debt - BioCryst Pharmaceuticals on 2023-04

Healthcare • Consulting • Logistics

BioCryst Pharmaceuticals, Inc. is a global biotechnology company focused on the discovery, development, and commercialization of novel oral small-molecule and protein therapeutics for rare diseases, notably hereditary angioedema (HAE). Founded in 1986, BioCryst uses structure-guided drug design, medicinal chemistry, and advanced technologies to develop first-in-class or best-in-class medicines, and works closely with patients, advocacy groups, and global partners to bring treatments to market.

📋 Description

• Administer the BioCryst Document Control System in compliance with company SOPs, Quality Systems, applicable cGMPs, and regulatory requirements • Serve as Document Control/eDMS/QMS administrator • Provide new user accounts, training, and support for Veeva eDMS/QMS • Review, update, file, distribute, and maintain controlled documents and templates • Coordinate approval, upload, and filing of controlled documents in Veeva, ComplianceWire, and SharePoint • Support document life-cycle, retention, biennial review, retrieval, and archiving procedures • Maintain Master Content Lists and tracking sheets for quality documents • Assist with preparation of quality metrics for QA management presentations • Administer and support the GxP Training Program and ComplianceWire LMS • Assign and track employee training and maintain electronic training files • Support training of departmental ComplianceWire Content Administrators • Administer the Vendor Management Program, including reassessments, trackers, change controls, and vendor qualification documentation • Review vendor assessment documentation for completeness and coordinate timely distribution and internal review • Maintain electronic vendor folders and related assessment records • Support validation and implementation processes for Quality Systems • Provide cross-functional support within the QA department • Manage presentation versions, meeting minutes, and action items for critical business meetings • Perform proofreading, editing, word processing, and filing • Perform other duties as assigned

🎯 Requirements

• 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 • Strong technical computer skills • Proficiency in Microsoft Word, Excel, PowerPoint, One Drive, and SharePoint • Experience with any Veeva environment desired • Knowledge of FDA regulations and industry standard guidelines for electronic records, including 21 CFR Part 11 • Knowledge of US FDA GMP requirements and associated guidelines • Strong analytical and problem-solving skills • Strong organizational skills and attention to detail • Ability to manage and complete multiple projects with minimal oversight • Ability to work successfully in a fast-paced, team-oriented environment • Ability to maintain confidentiality and work with sensitive documents • Ability to adapt to changing priorities effectively • Demonstrated ethical conduct, ownership of actions, and goal focus

🏖️ 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 • Professional and personal growth opportunities • People-first culture • Employee input into company goals and business objectives