Senior Clinical Quality Assurance Associate

🕒 July 22

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 34%

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💼 Consulting

📦 Logistics

💊 Pharmaceuticals

Consulting • Logistics • Pharmaceuticals

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

• Oversee, implement, and continuously improve GCP quality systems supporting global clinical operations • Provide quality leadership to operational teams and ensure compliance with ICH GCP, global regulatory requirements, Sponsor expectations, and internal QMS processes • Serve as GCP quality systems subject matter expert across global clinical operations • Provide QA oversight to Clinical Operations, Nursing, Project Management, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and other operational teams • Lead investigations for non-conformances, complaints, protocol deviations, quality events, and compliance issues • Independently manage complex CAPAs from investigation through effectiveness checks and closure • Lead risk assessments for new services, processes, vendors, systems, and operational changes • Review clinical and GCP documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents • Oversee decentralized clinical trial activities, including nursing, home healthcare, source documentation, IP handling, and related processes • Support QMS records and documentation, including deviations, CAPAs, complaints, change controls, risk assessments, SOPs, forms, templates, and guidance documents • Review change controls, support approvals, and lead post-implementation effectiveness reviews • Support vendor qualification, audits, requalification, Quality Technical Agreements, and ongoing vendor performance monitoring • Support audits and inspections by managing readiness, documentation, responses, corrective action plans, evidence, and commitment tracking • Review quality metrics, identify trends and risks, drive improvements, support validation/qualification activities, mentor QA staff, represent Quality on cross-functional projects, escalate significant risks, and promote a culture of quality and compliance

🎯 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 • Ability to manage multiple priorities, handle confidential information professionally, and apply a proactive, solutions-focused mindset • Resume must be submitted in English • Candidates must reside in a U.S. state where the company is authorized to hire • Candidates cannot reside in California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, or the District of Columbia

🏖️ Benefits

• Medical, dental, and vision insurance • FSA and 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 and paternity leave • Wellness, growth and development, and team relationship initiatives • Team events • Smoke-free, drug-free, and alcohol-free work environment