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 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.
The Ideal Candidate:
Solutions-drivenCritical thinkerStrong communicatorAdaptable
What You'll Do:
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.
What You'll Need:
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 environmentPractical 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 managementAbility to apply a risk-based approach to prioritize tasks effectively in day-to-day activitiesProven ability to work cross-functionally on new processes, investigations, root cause analysis, and continuous improvement initiativesStrong critical thinking and analytical skills, particularly in conducting and reviewing investigationsExcellent organizational, planning, time management, and administrative skills, with high attention to detail and accuracy under strict deadlinesEffective verbal and written communication skills, with the ability to manage stakeholders, drive projects independently, and communicate business needs with minimal supervisionHighly self-motivated, adaptable, solutions-oriented, and able to work independently under pressure, with strong interpersonal skills and proficiency in Microsoft Office, particularly Excel
What We Offer:
Medical, dental, and vision insurance, FSA, HSA
Voluntary short-term and long-term disability insurance
Voluntary life insurance
401K safe harbor plan and company match
Paid vacation, holiday, and sick time
Paid maternity & paternity leave
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:
WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.
We're Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
