Director, Quality Operations

🕒 il y a 2 jours

🎸 Tennessee – Distant

🎸 Tennessee – Remote

⏰ Temps Plein

🔴 Expert

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LabConnect

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2002

🏥 Santé

💊 Pharmaceutique

🧬 Biotechnologie

💰 €24 500 000 Series A - LabConnect en 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect est un partenaire mondial de solutions de laboratoire central qui fournit des services de laboratoire et de données technologiquement avancés, personnalisés, orchestrés et évolutifs pour soutenir les essais cliniques et le développement de médicaments dans le monde entier. Ses offres incluent des tests bioanalytiques centraux et spécialisés, un soutien radiopharmaceutique, une collecte décentralisée/près du domicile, des kits de collecte personnalisés et des kits à grand volume, des diagnostics compagnons et la validation d'essais, la gestion et l'harmonisation des données, la gestion de projets réglementaires et scientifiques, ainsi qu'un soutien commercial/post-commercialisation. LabConnect sert les promoteurs et CROs dans divers domaines thérapeutiques (oncologie, vaccins, thérapie cellulaire et génique/ATMP, et plus encore), en mettant l'accent sur la supervision des programmes et l'exécution opérationnelle pour la recherche clinique.

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

🎯 Exigences

• 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

🏖️ Avantages

• Minimal travel requirements