Senior Quality Assurance Associate

WEP Clinical•Morrisville, NC

About The Position

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. The Senior Quality Assurance (QA) Associate plays a critical role within the Quality team, ensuring that pharmaceutical distribution and manufacturing activities are conducted in compliance with applicable regulatory standards (e.g., UK/EU/FDA GMP, GDP, and national health authority requirements). The role focuses on the daily oversight, execution, and improvement of quality processes and supporting client project delivery for the Post-Approval Named Patient (PA-NPP), Expanded Access Progamme (EAP), Commercial and Clinical Trial supply service lines.

Requirements

Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
2-5 years of experience in a Quality-related role within a regulated environment
Practical experience in GxP Supply Chain, Production, and Quality Assurance, with knowledge of GMP, GDP, and the supply of unlicensed medicines (including distribution supply chains and unlicensed pathways preferred)
Strong understanding of core Quality Management System processes, including risk assessments, deviations, change control, and supplier/customer management
Ability to apply a risk-based approach to prioritize tasks effectively in day-to-day activities
Proven ability to work cross-functionally on new processes, investigations, root cause analysis, and continuous improvement initiatives
Strong critical thinking and analytical skills, particularly in conducting and reviewing investigations
Excellent organizational, planning, time management, and administrative skills, with high attention to detail and accuracy under strict deadlines
Effective verbal and written communication skills, with the ability to manage stakeholders, drive projects independently, and communicate business needs with minimal supervision
Highly self-motivated, adaptable, solutions-oriented, and able to work independently under pressure, with strong interpersonal skills and proficiency in Microsoft Office, particularly Excel

Responsibilities

Ensure GMP and GDP compliance across all regulated activities, maintaining best practices at all times.
Prioritize and oversee compliance activities related to Wholesaler and Manufacturing Licenses/Authorisations in line with regulatory expectations.
Manage key quality processes, driving operational compliance and identifying risks to patient safety, product quality, or regulatory adherence with effective mitigation strategies.
Monitor, trend, and analyze quality incidents and metrics, proposing improvements to prevent recurrence and support management review.
Lead and coordinate investigations for deviations, non-conformances, and complaints, ensuring robust root cause analysis and effective CAPA implementation.
Initiate and support risk assessments, validation protocols, periodic reviews, and other quality system activities, including post-effectiveness checks for CAPAs and Change Controls.
Drive timely completion and closure of critical quality records, ensuring appropriate supporting evidence is in place.
Lead and support change controls, assessing impacts and risks and implementing necessary mitigating actions.
Coordinate product recalls and mock recalls as required.
Create, maintain, review, and archive GxP documentation, ensuring controlled document updates and effective document lifecycle management.
Develop and execute validation and qualification strategies for shippers, equipment, facilities, IT systems, and warehouse operations, ensuring GMDP compliance.
Support product disposition from quarantine, perform batch reviews, line clearances, quality inspections, label reviews, and secondary packaging oversight in accordance with SOPs.
Support batch certification activities, including completion of Product Specification Files and escalation of quality issues to the Qualified Person as needed.
Provide quality oversight and support for commercial, clinical trial, and supply chain projects, including client calls, technical agreements, audits, and regulatory inspections.
Contribute to internal and external audits, supplier and vendor qualification, training, and continuous process improvements while promoting collaboration across the global Quality team and wider business.