Senior Quality Assurance Lead

Description Join to apply for the Senior Quality Assurance Lead role at Emerald Clinical The Senior Quality Assurance Lead ensures that quality management processes and activities undertaken by Emerald Clinical are conducted in compliance with applicable codes, regulations and principles through initiatives identified in the Clinical Research Quality Management System (CRQMS). They verify all clinical research activities are conducted in compliance through audit, training, project support, and quality management activities. The incumbent may be assigned additional responsibilities globally or in other countries and works closely with other Quality team members, project operations, data science, medical, regulatory and safety services staff to support quality across all company activities for the designated countries. Responsibilities Provide ongoing advice and support to company personnel regarding application and interpretation of SOPs, regulatory requirements and GCP standards. Monitor and provide input into the CRQMS to reflect regional needs, recommending initiatives for continuous improvement as needed. Support project teams to proactively assess risk and embed quality into trials and address any quality issues, in accordance with the CRQMS. Identify, report, and elevate compliance and quality issues and emerging risks to Global Head, Quality and Line Manager as a priority, and where applicable to the relevant Project Lead. Review local CAPA and provide feedback and guidance as needed. Support and contribute to global SOP/WI management, working with country representatives and relevant functional area authors to reflect local conditions and regulatory requirements as needed. Assist with maintenance of company policies/SOPs/WIs as requested by Director, Quality Processes. Provide support to functional areas/project teams for hosting third‑party site audits, sponsor audits and inspections. Assist with collation of quality metrics. Deliver Quality induction to new staff, as needed. Participate in regional/local and functional area meetings as required, sharing and discussing quality‑related topics. Stay abreast of local and global GCP and relevant regulatory trends and advise relevant stakeholders accordingly. Provide regular reports to Quality Management on the progress of all quality activities for the designated country(ies). Qualifications Tertiary qualifications in a health‑related field, or relevant equivalent work experience. At least 7‑8 years of experience in the clinical operations/project management/quality assurance or quality management field including phase II‑IV global studies. Experience and/or qualifications in the development, delivery, and facilitation of training to clinical research staff desirable. About Emerald Clinical Emerald Clinical is a global contract research organization dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases. Why Join Us? Purpose‑Driven Work : Contribute to trials that genuinely improve lives in renal, cardiometabolic, and oncology. Global Reach, Local Expertise : Build trust and meaningful engagement in local communities. Collaboration and Innovation : Work in a culture that values diverse perspectives and creative solutions. What We Offer Competitive Compensation : A tailored salary and benefits package. Flexibility : Hybrid or remote working arrangements depending on location and role. Career Growth : Access to learning opportunities and a global network of scientific leaders. Employee Wellbeing : Programs and initiatives promoting work‑life balance, health, and team connection. Global Opportunities : Exposure to diverse projects and clients. How to Apply Interested? Apply now and help us achieve our mission to improve the health of millions worldwide. We are an equal‑opportunity employer and encourage applications from all qualified candidates. Seniority Level Not Applicable Employment Type Other Job Function Quality Assurance #J-18808-Ljbffr Industry Other Category Management & Operations Sub Category Quality Management & Operations