Senior Quality Manager

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Provides functional and project-level quality oversight across assigned scope • Ensures compliance with GCP and other applicable GxP regulations • Supports and participates in eQMS lifecycle activities, including validation oversight activities, as required • Oversees and performs vendor quality management activities, including qualification, risk assessment, and RFIs; reviews and approves outputs generated by Quality Managers • Supports business units and clients on projects, including development and maintenance of project-specific quality frameworks and procedures • Generates, reviews and approves controlled documents; ensures consistency, regulatory compliance, and alignment with the QMS • Manages quality issues and CAPAs, including oversight of investigations, escalation of significant risks or delays, and decision-making on critical issues and suspected serious breaches • Participates in quality risk management activities, including risk identification, assessment, and review

🎯 Requirements

• Bachelor's degree in Life Sciences (or equivalent experience) • 5+ years in quality management/QA • 5+ years in GxP auditing - nice to have • Strong expertise in GCP/GxP, QMS, and system validation • Proven ability to work independently and lead complex quality activities

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth