Vice President, Quality Assurance

🔥 4 hours ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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LabConnect

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2002

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $24.5M Series A - LabConnect on 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect is a global central laboratory solutions partner that provides technology-driven, customized, orchestrated, and scalable laboratory and data services to support clinical trials and drug development worldwide. Its offerings include central and specialty bioanalytical testing, radiopharmaceutical support, decentralized/near-home collection, custom collection kits and high-volume kitting, companion diagnostics and assay validation, data management and harmonization, regulatory and scientific project management, and commercial/post-market support. LabConnect serves sponsors and CROs across multiple therapeutic areas (oncology, vaccines, cell and gene therapy/ATMPs and more), emphasizing program oversight and operational execution for clinical research.

📋 Description

• Build and lead an effective global Quality Assurance team • Ensure data privacy, quality oversight and regulatory compliance • Oversee all GxP activities and Quality Management System performance • Lead and collaborate with Operations, Quality and other functions on quality matters, escalations and regulatory requirements • Serve as Data Privacy Officer • Oversee quality assurance and quality control activities, metrics and quality culture initiatives • Support vendor, client and internal audit programs, including vendor qualification, monitoring, CAPA and issue resolution • Ensure global quality team resourcing, expertise and processes comply with applicable regulations and client agreements • Create the annual strategic Quality Plan • Review regulatory and compliance risks in contractual negotiations and ensure clarity of client Quality agreements • Serve as quality and regulatory advisor to partners and clients • Represent LC Quality at forums • Provide quality guidance for strategic projects and plans • Ensure adequate GxP training and annual retraining for LC personnel • Maintain the Quality Management System and applicable quality processes and procedures • Monitor regulatory and industry requirements and best practices and implement improvements • Perform other related duties as assigned

🎯 Requirements

• Bachelor's degree from four-year college or university with 12-15 years related experience and/or training; or equivalent combination of education and experience • 10+ years of progressive experience in building and leading global teams in regulated environments (biotech, Central labs and/or Pharma companies) with a specific focus on Quality • Proven experience managing FDA inspections, client audits and quality oversight across drug development, approval and post market (GxPs) • Strongly preferred: Experience in clinical trials, clinical laboratory, FDA 21CRF11/GCP, GxP • Certifications and thorough understanding of applicable global regulations • Veeva Vault experience highly desired • Proven leadership/supervisory ability and experience • Strong analytical, planning and problem-solving skills • Ability to work effectively with the CQO as a strategic partner • Global work experience with teams and clients across cultures and time zones • Ability to adhere to established timelines, processes and procedures • Excellent attention to detail • Self-motivation and ability to work independently and collaboratively • Ability to adapt to changing environments and requirements • Ability to make quick and well-thought-out decisions • Excellent organization, time management, communication, multitasking, interpersonal and listening skills • Business acumen to drive quality culture while meeting short- and long-term business goals • Proficient in Microsoft Word, Excel, database software, Microsoft Office applications, finance software and technology • Ability to read, write and comprehend internal and external correspondence, meeting agendas and meeting notes • Ability to apply simple mathematical skills and abstract thinking • Ability to solve practical problems, investigate issues and draw logical conclusions • Ability to travel as needed/requested

🏖️ Benefits

• Ability to travel as needed/requested • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job