Clinical Quality Assurance Manager

WEP Clinical

Senior Clinical Quality Assurance Associate overseeing GCP quality systems for WEP Clinical’s global clinical trial and patient-care services. Leading audits, CAPAs, QMS improvements, vendor oversight, and decentralized trial quality activities.

Posted 8/5/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in overseeing and improving GCP quality systems, managing clinical quality activities, and leading quality investigations and audits. Proficient in regulatory compliance, risk management, and stakeholder collaboration within global clinical operations.

Highest-signal resume keywords

GCP Quality Systems ManagementClinical Quality LeadershipRegulatory Inspections and AuditsQuality Management Software ApplicationsRisk-Based Quality Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Quality ManagementQuality InvestigationsCAPA ManagementRoot Cause AnalysisQuality Risk AssessmentRegulatory ComplianceQuality Metrics TrackingProtocol ReviewEQMSETMF

Soft Skills

Project ManagementAttention to DetailCommunicationAnalytical SkillsStakeholder Management

Tools & Technologies

Microsoft OfficeQuality Management Software

Industry Keywords

Clinical TrialsCROPharmaceuticalBiotechnologyHealthcareICH E6(R3)FDAEU CTRMHRAGDPR

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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