Job Title

*Please note this person MUST have extensive GCP experience*Manager, Quality Assurance (QA) & ComplianceWe are a dynamic Clinical Trial Management Organization (CRO) providing Phase IIIIB full-service support to biotechnology and biopharmaceutical companies. We make a difference by collaborating in life sciences to improve the lives of patients.The Manager, Quality Assurance & Compliance is responsible for maintaining Quality Management Systems (QMS) and practices that align with customer and regulatory requirements. This role involves investigating, analyzing, and reporting compliance activities, as well as participating in sponsor and regulatory audits. Additionally, the Quality Manager will provide training and support to raise awareness and visibility of quality initiatives across the organization.Roles and Responsibilities:Oversight of QMS, including Standard Operating Procedure (SOP) review and developmentDevelopment and implementation of an annual Quality PlanConduct internal Quality Control (QC) audits of studies and processesPerform external vendor due diligence/qualification audits in collaboration with stakeholdersSupport investigative site audits and aid sites in preparing for regulatory inspectionsDeliver current Good Clinical Practice (GCP) and related training to internal and external stakeholdersProvide GCP and Quality support to both internal team members and external collaboratorsManage, coordinate, and facilitate all sponsor audits and regulatory inspections across multiple jurisdictions, including follow-up and response coordinationPerform quarterly trend analyses of audit findingsReview non-conformance reports, deviations, and corrective and preventive actions (CAPA)Manage CAPA processes and reviews, representing Quality as assignedEstablish and track trends and metrics related to Quality System processesSupport training initiatives related to Quality System requirements and complianceObserve and enforce Quality Policy, Quality Manual, and Quality System ProceduresProvide guidance to various functional groups (Clinical Operations, Finance, IT, and more) to aid complianceKeep stakeholders updated on progress, issues, and follow-up actionsQualities & Skills:Collaborative team playerSelf-motivated, adaptable, and eager to contribute to collective goalsPersonable and communicative able to foster strong relationshipsAbility to work effectively under pressure and manage competing prioritiesDetail-oriented with strong organizational and time-management skillsAbility to make decisions with stakeholders perspectives in mindExcellent written and verbal communication skillsStrong knowledge and understanding of ICH GCPFamiliar with applicable regulations (such as Health Canada Division 5 and FDA regulations)Ability to solve problems creatively and independentlyWillingness to travel as neededFlexible and able to handle multiple tasksAbility to remain productive and focused under pressureCollaborative, team-oriented, and adaptableAbility to apply common sense and a pragmatic approach to difficult problemsPlease apply here or send your cv to