Clinical Quality Assurance Manager

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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 and decentralized clinical trials • Provide quality leadership and strategic quality advice to operational teams and departments • Manage day-to-day Clinical Quality team activities, including workload planning, performance management, coaching, training, and professional development • Oversee QMS records, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and quality events • Review and approve investigations and monitor CAPA effectiveness • Track inspection trends, quality metrics, KPIs, and emerging compliance risks • Provide quality oversight for nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical processes • Lead quality oversight for new services, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation • Review clinical trial documentation including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents • Support vendor qualification and oversight, audits, requalification, Quality Technical Agreements, and vendor performance monitoring • Lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits • Drive continuous improvement, QMS updates, quality governance, risk-based decision-making, stakeholder collaboration, patient safety, and operational excellence

🎯 Requirements

• Bachelor's Degree or higher; preference for pharmaceutical, life sciences, or engineering concentration • 5–7 years’ experience in a Clinical Quality related role • Minimum 2–3 years of people leadership or supervisory experience preferred • Experience within a CRO, pharmaceutical, biotechnology, healthcare, or other regulated clinical environment • Demonstrated experience supporting global clinical trials and decentralized clinical trial activities • Experience leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits • Practical experience leading quality investigations, CAPAs, root cause analyses, and quality risk assessments • Experience with eQMS, eTMF, Microsoft Office, and quality management software applications • Strong knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR where applicable, and other global regulatory expectations • Strong understanding of risk-based quality management, computerized system validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable • Ability to manage multiple quality activities in a fast-paced global environment • Strong organization, project management, attention to detail, communication, analytical, stakeholder management, and influencing skills • Ability to work effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams • Resume must be submitted in English • Candidates must reside in a U.S. state where the company is authorized to hire; the role is not eligible for residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia

🏖️ 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 • Wellness, growth and development initiatives • Team events • Inclusive, supportive work environment