Senior Clinical Quality Assurance Associate

WEP Clinical

2d•Remote

About The Position

The Senior Clinical Quality Assurance Associate is responsible for the oversight, implementation, and continuous improvement of GCP quality systems supporting global clinical operations across all clinical activities, including decentralised clinical trials (DCTs) that involve nursing services and in-home patient care. This role provides quality leadership to operational teams by ensuring compliance with ICH GCP, applicable global regulatory requirements, Sponsor expectations, and internal Quality Management System (QMS) processes.

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
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

Nice To Haves

Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous

Responsibilities

Serve as GCP quality systems SME 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.