wepclinical - Senior Clinical Quality Assurance Associate
Requirements
• Attention to detail • 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.
Responsibilities
• 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.
Benefits
• Medical, dental, and vision insurance • 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. • Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/ • 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-hybrid
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