Senior Quality Assurance Associate

About the role

The is a pivotal position dedicated to upholding the highest standards of regulatory compliance and operational excellence. This role is responsible for driving quality initiatives that directly impact the integrity of pharmaceutical distribution and patient safety. You will own the execution of quality processes that ensure adherence to UK, EU, and FDA regulations across multiple service lines. The position requires a proactive mindset to identify risks and implement controls that prevent deviations before they occur. You will act as a subject matter expert, guiding the team through complex regulatory landscapes with precision and confidence. This role is instrumental in fostering a culture of quality and continuous improvement within the organization.

About the role

WEP Clinical is seeking a Senior Quality Assurance Associate to join our mission-focused team. This role is central to driving impactful solutions that improve outcomes for clients and patients. We foster an environment of innovation and collaboration, encouraging team members to develop ideas that create meaningful change. This is a position for a dedicated professional committed to advancing clinical research and transforming lives through meticulous execution. The Senior Quality Assurance Associate is a critical member of the Quality team, responsible for ensuring all pharmaceutical distribution and manufacturing activities adhere to applicable regulatory standards. This includes compliance with UK/EU/FDA Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and specific national health authority requirements. The associate provides daily oversight, execution, and continuous improvement of quality processes. This role is specifically focused on supporting key service lines, including Post-Approval Named Patient (PA-NPP), Expanded Access Programme (EAP), Commercial, and Clinical Trial supply. The ultimate goal is to safeguard client and patient safety while ensuring product integrity.

What you'll do

You will design and establish intake protocols for project requests, rigorously confirming scope and identifying all applicable regulatory requirements prior to execution. The role involves authoring detailed testing procedures and comprehensive documentation that strictly conform to UK/EU/FDA GMP, GDP, and national health authority mandates. You will conduct thorough reviews of process outputs and batch records to detect any inconsistencies or deviations, ensuring all release criteria are met without exception. Final product distribution requires meticulous coordination; you will manage the shipping logistics for Commercial and Trial supply lines in collaboration with clients and partners. You will partner with internal stakeholders to analyze, document, and refine workflows specific to PA-NPP and EAP service lines to enhance efficiency. The position includes providing direct coaching and mentorship to junior quality staff, ensuring they execute EAP and Clinical Trial activities with absolute compliance. You will analyze system performance metrics to validate the ongoing stability and effectiveness of quality management processes. A critical ongoing duty is the enhancement of documentation systems to ensure distribution and manufacturing records are robust, traceable, and audit-ready.

Requirements

Candidates must possess 3-5 years of experience overseeing quality activities within pharmaceutical manufacturing or clinical research environments. A deep and demonstrable knowledge of regulations for the UK, EU, and United States health authorities is mandatory for this role. You must have specific hands-on experience with GDP, GMP, and the expectations of national health authorities regarding supply chain and distribution operations. Proven ability in managing projects for PA-NPP, EAP, Commercial, and Clinical Trial supply lines is an essential prerequisite. Clear, concise, and effective communication skills are required to update clients and partners regarding quality status, decisions, and remediation plans. You must be capable of operating independently with minimal supervision while functioning effectively within cross-functional teams. The role demands meticulous attention to detail and the ability to manage complex tasks with accuracy and consistency. You must be willing to adhere strictly to company policies and regulatory guidelines without exception.

Nice to have

Prior professional experience within the life sciences or clinical research organization (CRO) sector is strongly preferred for this position. Familiarity and comfort level using technology platforms for quality management, document control, and data tracking will be considered a distinct advantage.

Skills & Tools

No specific software or tools are listed as mandatory requirements for this position.

Practical notes

Location: USA

Engagement: Full-Time.

Compensation: $130,000 to $150,000 USD per year.