Director, Quality Operations

🕒 August 5

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🔴 Lead

⚙️ Operations

👻 Ghost score 12%

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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

• Develop and execute the annual US Quality Plan aligned with global strategy • Provide oversight of US Quality Assurance operations and Global Quality Control • Advise US Operations and senior leadership on quality strategy, regulatory requirements, and compliance risks • Lead strategic projects that enhance quality culture and improve processes and outcomes • Oversee design verification and quality control review processes • Direct study QC support documentation reviews • Establish and monitor US QA and Global QC metrics; report outcomes and recommend improvements • Participate in quality-event investigations and CAPA planning • Author, review, and approve Project Quality Control SOPs • Coordinate and host client audits and prepare the organization for regulatory inspections • Collaborate across departments to align QC reviews with current processes and standards • Provide regulatory and compliance risk reviews of contractual negotiations • Partner with global QA and IT staff on systems validation and compliance initiatives • Supervise, coach, and develop Quality Control Specialists and other team members • Oversee training-material creation and staff readiness for evolving quality standards • Interface with laboratory, customer service, business development, project management, IT, and data management teams

🎯 Requirements

• Bachelor’s degree in life sciences or related field (required) • 10+ years of experience in a clinical or laboratory environment with increasing responsibility in quality assurance/control (required), or a combination of roles in Life Sciences focused on Quality and Regulatory • 4+ years of leadership experience, including direct supervision of teams (required) • Experience in clinical trials and laboratory environments with focus on GCP/GxP (preferred) • Global work experience with teams and clients across cultures and time zones (preferred) • Research Quality Association Cert-GCP or Cert-GCLP, or EOQ Certified Quality Auditor (preferred) • Proven ability in quality/regulatory leadership • Strong planning, problem-solving, and risk management skills • Excellent attention to detail and ability to adapt to changing environments • Effective communication, public speaking, interpersonal, and listening skills • Demonstrated business acumen and ability to make timely, well-considered decisions • Excellent organization and time management skills • Proficiency in Microsoft Word, Excel, and database software • Fluent in English; additional language skills are a plus • Ability to perform prolonged desk, computer, headphone, phone, video, and email work • Minimal travel availability

🏖️ Benefits

• Minimal travel requirements