Senior Clinical Quality Assurance Associate

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives

The WEP Clinical GMDP Quality Assurance Manager will be responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities. They will oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements. The GMDP Quality Manager will also 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.

The Ideal Candidate

• Attention to detail

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Process-driven

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Accountable

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Collaborative

What You'll Do

• 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.

What You'll Need

• 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