The Role
Provide GCP quality systems leadership for global clinical operations, overseeing decentralized trial activities, leading investigations and CAPAs, managing risk assessments, reviewing clinical/GCP documents, supporting audits/inspections and vendor qualification, driving QMS improvements, and mentoring QA staff to ensure regulatory compliance and continuous quality improvement.
Summary Generated by Built In
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 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.
The Ideal Candidate:
- Attention to detail
- Process-driven
- Accountable
- 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
Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.
What We Offer:
Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick and volunteer time
Paid maternity & paternity leave
What Sets Us Apart:
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.
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 we do to support our employees.
How We Work at WEP Clinical:
At WEP Clinical, we look for individuals who are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.
Our Services Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialization
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.
Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any stage of recruitment
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.
#LI-Fulltime #LI-remote
Skills Required
- Bachelor's degree or higher
- 3 to 5 years in a quality-related role within CRO, pharma, biotech, or healthcare
- Experience supporting global clinical trials and decentralized clinical trial activities
- Experience supporting sponsor audits, regulatory inspections, internal audits, or supplier audits
- Practical experience with quality investigations, CAPAs, root cause analysis, and risk assessments
- Experience with eQMS, eTMF, Microsoft Office, and quality management software applications
- Working knowledge of GCP, ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, GDPR
- Understanding of Quality Management Systems, risk-based quality management, and validation lifecycle principles
- Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes
- Strong analytical, organizational, communication, stakeholder management, mentoring, and influencing skills
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The Company
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
