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 Clinical Quality Assurance Manager is responsible for the strategic leadership, oversight, and continuous improvement of the Good Clinical Practice (GCP) Quality Management System (QMS) supporting global clinical operations, including decentralised clinical trials (DCTs) involving nursing services and in-home patient care. This role is accountable for ensuring quality systems remain compliant with ICH GCP, applicable global regulatory requirements, Sponsor expectations, and internal quality standards while fostering a culture of quality, risk management, operational excellence, and continuous improvement.
The Clinical Quality Assurance Manager provides leadership to the Clinical QA team, partners with operational leadership across the organization, and serves as the primary quality advisor for clinical operations, regulatory inspections, Sponsor audits, and strategic business initiatives.
Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
5-7 years’ experience in a Clinical Quality related role
Minimum 2–3 years of people leadership or supervisory experience preferred.
Experience within a CRO, pharmaceutical, biotechnology, healthcare, or other regulated clinical environment.
Demonstrated experience supporting global clinical trials and decentralized clinical trial activities.
Experience leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits.
Practical experience leading quality investigations, CAPAs, root cause analyses, and quality risk assessments.
Experience with eQMS, eTMF, Microsoft Office, and quality management software applications.
Strong knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR where applicable, and other global regulatory expectations.
Strong understanding of risk-based quality management, computerized system validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable.
Ability to manage multiple quality activities in a fast-paced global environment with strong organization, project management, and attention to detail.
Strong communication, analytical, stakeholder management, and influencing skills, with the ability to work effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams.
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.
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
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
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/
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.
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.
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.
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At WEP Clinical, we operate as a specialist CRO with a proven track record of excellence in designing, managing, and executing Clinical Trials, Expanded Access Programs (EAPs), and Commercialization Solutions across the globe. Through our strong customer service and proactive project management, we are committed to scientific integrity, regulatory compliance, and patient-centric research, helping Sponsors advance their life-changing therapies while providing greater access opportunities for patients.
We specialize in the following:
- Clinical Trial Management
- Expanded Access Programs
- Post-Approval Named Patient Programs
- Market Access Solutions
- Mobile Research Nursing Services
- Clinical Trial Sourcing.
We are With Every Patient, as we believe every patient should have access to treatment!
We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
