Job Title

**MUST HAVE** 3+ years in a quality assurance or regulatory compliance role within the clinical research, pharmaceutical, biotechnology, or life sciences industry.Quality Assurance (QA) & Compliance SpecialistLocation: Remote or Office-Based (as applicable)A dynamic and forward-thinking clinical research organisation is seeking a Quality Assurance & Compliance Specialist to support the maintenance and continuous improvement of its Quality Management System (QMS). The organisation provides full-service clinical trial management support for early to mid-phase studies, collaborating closely with partners across the life sciences sector to positively impact patients' lives.The successful candidate will play a key role in ensuring the organisations quality standards and regulatory compliance are consistently met. This is a self-directed role requiring strong attention to detail, the ability to manage multiple priorities, and a proactive approach to quality initiatives across the business.Reports to: Chief Operating Officer (COO)Key ResponsibilitiesMaintain and manage the Quality Management System, including Standard Operating Procedures (SOPs), Work Instructions (WIs), templates and associated forms.Oversee the communication, distribution, and tracking of QMS documentation.Ensure accurate and timely electronic filing of all QA and training-related documents (e.g., SOPs, Corrective and Preventive Action reports, training files).Manage oversight and tracking of CAPAs, deviations, and administrative correspondence.Track audit access and documentation across sponsor, vendor, and internal audits.Develop and maintain the annual quality plan, including quarterly updates, signature tracking, and distribution.Support the conduct of internal Quality Control (QC) audits for organisational studies and processes.Assist with the coordination and execution of external vendor due diligence and qualification audits.Provide training on Quality System requirements and ensure organisation-wide compliance.Promote awareness of the Quality Policy, Quality Manual, and related procedures across all departments.Work collaboratively with cross-functional teams, including Clinical Operations, Business Development, Finance, and IT.Keep the COO informed of progress, developments, and issues within the QA function.Key RequirementsStrong cultural fit; aligned with the organisations values and purpose.Self-motivated, proactive, and committed to achieving high standards.Ability to manage multiple tasks and priorities under time pressure.Excellent interpersonal and communication skills; approachable and professional.Comfortable in a fast-paced, collaborative team environment.Solid understanding of ICH-GCP, Health Canada Division 5, and FDA regulations.Meticulous attention to detail with strong organisational skills.Effective time management and a structured approach to workload and deadlines.Reliable and accountable; follows through on commitments.Team player who contributes positively to team dynamics.Capable of working both independently and collaboratively.Adaptable and flexible in response to changing priorities.Excellent written and verbal communication skills in English.Willingness to travel when required.Practical, confident, and solutions-focused.To +441293778666