[Hiring] Senior Clinical Quality Assurance Associate @WEP Clinical

Role Description

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 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.

Qualifications

• Attention to detail
• Process-driven
• Accountable
• Collaborative

Requirements

• 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.

Benefits

• 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

Company Description

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.

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.

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.

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization