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 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.
The Ideal Candidate:
- Proactive and self-motivated
- Calm and logical under pressure
- Confident communicator
- Strong leadership mindset
What You'll Do:
- Manage day-to-day Clinical Quality team activities, including workload planning, prioritization, performance management, coaching, training, and professional development.
- Provide cross-functional oversight of the GCP Quality Management System to ensure compliance with applicable regulations, Sponsor requirements, and company procedures.
- Serve as the functional leader and strategic quality advisor for GCP quality activities across global clinical operations and operational departments.
- Oversee QMS records, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and quality events.
- Review and approve investigations, ensuring they are robust, risk assessed, completed within timelines, and supported by appropriate corrective and preventive actions.
- Monitor CAPA effectiveness, inspection trends, quality metrics, KPIs, and emerging compliance risks to identify systemic improvement opportunities and mitigation strategies.
- Provide quality oversight for decentralized clinical trial activities, including nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical processes.
- Lead quality oversight for new services, processes, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation activities impacting GCP operations.
- Oversee quality reviews of clinical trial documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, essential documents, and other applicable GCP documentation.
- Support vendor qualification and oversight, including quality risk assessments, audits, periodic requalification, Quality Technical Agreements, and ongoing vendor performance monitoring.
- Lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits, including inspection readiness, documentation review, audit responses, and commitment tracking.
- Drive continuous improvement, QMS documentation updates, quality governance, risk-based decision-making, stakeholder collaboration, and a proactive culture of quality, compliance, patient safety, and operational excellence.
What You'll Need:
- 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.
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
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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