[Hiring] Clinical Quality Assurance Manager @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 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.

Qualifications

• Proactive and self-motivated
• Calm and logical under pressure
• Confident communicator
• Strong leadership mindset

Requirements

• 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

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