Senior Quality Assurance Manager - GCP

Our Client are a dynamic and rapidly growing organisation committed to advancing clinical research and improving patient care. Their mission is to drive excellence in clinical trials through a culture of quality, compliance, and continuous improvement. They are seeking a highly skilled and passionate Head of Quality Assurance (QA) to join their leadership team and champion the delivery of high-quality clinical research across the organisation. Role Overview:The Head of Quality Assurance will be a key leadership figure responsible for driving and embedding a quality mindset throughout the organisation. This individual will be instrumental in promoting quality assurance and compliance in clinical trials, ensuring alignment with Good Clinical Practice (GCP), regulatory requirements, and internal standards. You will work closely with cross-functional teams, line managers, and Clinical Operations to ensure the highest standards of data integrity, patient safety, and operational efficiency. The ideal candidate will possess a strong blend of strategic thinking and hands-on execution, with exceptional communication and leadership skills to foster collaboration across departments. You will play a pivotal role in managing the Quality Management System (QMS), overseeing audit programs, developing risk management strategies, and leading a talented QA team. Your leadership will be vital in ensuring compliance, improving quality systems, and advancing the organisation's quality objectives. Key Responsibilities:Quality & Compliance Oversight:Risk Management & Continuous Improvement:Clinical Trial Monitoring & Auditing:Training & Development:Vendor Management:Asset, Equipment & System Management:Strategy & Leadership Qualifications & Experience:Education: Tertiary qualification in health, life sciences, or a related field (advanced degree preferred, e.g., MS, PhD).Experience: At least 8-10 years of experience within the pharmaceutical, biotechnology, or CRO environment, with a minimum of 5 years in a quality assurance or compliance role.Clinical Trial Experience: Hands-on experience in the Phase 1 clinical trial environment is preferred.Regulatory Knowledge: Strong understanding of ICH GCP and other national and international regulatory guidelines and requirements.Leadership: Proven experience in leading and managing a QA team, fostering a collaborative and high-performance culture.Technical Skills: Proficiency with electronic quality management systems and tools; strong clinical writing and documentation skills.Audit & Compliance: Experience in conducting audits, inspections, and implementing corrective and preventive actions (CAPAs).Vendor Management: Experience in managing vendors and ensuring compliance with quality standards. Skills & Competencies:Behavioural Skills:Strong problem-solving, analytical, and decision-making abilities.Exceptional interpersonal skills with the ability to collaborate across departments and influence stakeholders.Proactive, solution-oriented approach with a strong ability to work independently and as part of a team.Excellent leadership skills, capable of motivating and developing a high-performing team.A passion for quality, continuous improvement, and achieving the highest standards in clinical trials.Technical Skills:High level of IT literacy, with advanced proficiency in Microsoft Office Suite (Word, Excel, Projects) and database management tools.Strong technical writing and documentation skills for regulatory submissions and internal reports. Why Join?This is a unique opportunity to shape the quality assurance framework at a forward-thinking organisation. If you’re a driven leader with a passion for quality, continuous improvement, and clinical excellence, we’d love to hear from you. Join in delivering high-impact clinical research while fostering a culture of collaboration and quality across all levels of the organisation. How to Apply: Please submit your CV and a cover letter outlining your experience and suitability for the role to [email protected]. We look forward to hearing from you!