Senior Clinical Quality Assurance Associate

🔥 1 minute ago

🏄 California, Colorado, +7 more states – Remote

🏄 California – Remote ⛰️ Colorado – Remote 🏛️ District of Columbia – Remote 🌺 Hawaii – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

📋 Description

• Responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities. • Oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements. • Act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

🎯 Requirements

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration) • 3 to 5 years of experience in a quality-related role within a CRO, pharmaceutical, biotechnology, or healthcare organization • Experience supporting global clinical trials and decentralized clinical trial activities • Experience supporting Sponsor audits, regulatory inspections, internal audits, and/or supplier audits • Practical experience with quality investigations, CAPAs, root cause analysis, quality risk assessments, and continuous improvement • Experience with eQMS, eTMF, Microsoft Office, and quality management software applications • Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, GDPR where applicable, and related requirements • Strong understanding of Quality Management Systems, risk-based quality management principles, and computerized system validation or validation lifecycle principles • Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous • Strong analytical, organizational, communication, stakeholder management, mentoring, and influencing skills, with the ability to manage multiple priorities, handle confidential information professionally, and apply a proactive, solutions-focused mindset

🏖️ Benefits

• Medical, dental, and vision insurance • FSA, HSA • Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance • Group short-term and long-term disability insurance • Group Life Insurance • 401K safe harbor plan and company match • Paid vacation, holiday, sick and volunteer time • Paid maternity & paternity leave