Job Title

**MUST HAVE Minimum 57 years of Quality Assurance and Compliance experience within the clinical research or pharmaceutical industry, with proven expertise in GCP, QMS management, and regulatory audit coordination.**Manager, Quality Assurance (QA) & ComplianceLocation: Remote or Office-Based (as applicable)An innovative and collaborative clinical research organisation is seeking a Quality Assurance & Compliance Manager to oversee the development, implementation, and maintenance of Quality Management Systems (QMS) in alignment with industry standards and regulatory expectations. This role plays a key part in promoting a strong quality culture across the organisation and ensuring continued compliance within clinical operations.The successful candidate will act as a subject matter expert on quality and regulatory matters, supporting both internal teams and external stakeholders. They will manage audits, lead training on quality systems and Good Clinical Practice (GCP), and drive continuous improvement initiatives throughout the business.Key ResponsibilitiesOversee the organisations QMS, including the development, review, and maintenance of Standard Operating Procedures (SOPs).Develop and implement an annual Quality Plan, with regular updates and oversight.Lead internal Quality Control (QC) audits for clinical studies and organisational processes.Collaborate with consultants to conduct external vendor qualification and due diligence audits.Conduct investigative site audits as required and support sites in preparation for Regulatory Authority inspections.Deliver GCP and regulatory compliance training to both internal teams and external partners.Provide ongoing GCP and QA support across the organisation.Coordinate and manage regulatory inspections and sponsor audits across international offices, including preparation, facilitation, response, and follow-up.Facilitate external customer audits both pre- and post-contract award.Conduct quarterly trend analyses of audit findings to identify areas for improvement.Review and assess non-conformance reports, including SOP deviations and CAPAs.Manage the CAPA process and contribute to quality reviews.Maintain and report on data and metrics related to assigned quality systems processes.Support and ensure compliance with quality training activities across the business.Promote awareness of the organisations Quality Policy, Quality Manual, and relevant procedures.Partner with functional departments including Clinical Operations, Business Development, Finance, and IT to support quality-related initiatives and compliance.Provide regular updates on progress and emerging issues to senior leadership.Key RequirementsA strong fit with the organisations culture and values.Self-motivated with a proactive approach to problem solving.Personable, with strong communication and interpersonal skills.Comfortable working in a dynamic, fast-paced team environment.In-depth understanding of ICH-GCP, Health Canada Division 5, and FDA regulations.High level of accuracy and attention to detail.Excellent time management, organisational, and planning skills.Demonstrates accountability and delivers on commitments reliably.Able to balance competing priorities and meet deadlines.Confident and practical, with sound judgement and a collaborative mindset.Strong written and verbal communication skills in English.Capable of both independent and team-based work.Flexible and adaptable to changing circumstances.Analytical and strategic thinker with good research skills.Willingness to travel as required.To applygjohnstone@barringtonjames.com+441293778666