Description
<p>Please note this person MUST have extensive GCP experience</p><p><br></p><p>Manager, Quality Assurance (QA) & Compliance</p><p><br></p><p>We are a dynamic Clinical Trial Management Organization (CRO) providing Phase I–IIIB full-service support to biotechnology and biopharmaceutical companies. We make a difference by collaborating in life sciences to improve the lives of patients.</p><p><br></p><p>The <b>Manager, Quality Assurance & Compliance</b> 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.</p><p><br></p><p>Roles and Responsibilities:</p><ul><li>Oversight of QMS, including Standard Operating Procedure (SOP) review and development</li><li>Development and implementation of an annual Quality Plan</li><li>Conduct internal Quality Control (QC) audits of studies and processes</li><li>Perform external vendor due diligence/qualification audits in collaboration with stakeholders</li><li>Support investigative site audits and aid sites in preparing for regulatory inspections</li><li>Deliver current Good Clinical Practice (GCP) and related training to internal and external stakeholders</li><li>Provide GCP and Quality support to both internal team members and external collaborators</li><li>Manage, coordinate, and facilitate all sponsor audits and regulatory inspections across multiple jurisdictions, including follow-up and response coordination</li><li>Perform quarterly trend analyses of audit findings</li><li>Review non-conformance reports, deviations, and corrective and preventive actions (CAPA)</li><li>Manage CAPA processes and reviews, representing Quality as assigned</li><li>Establish and track trends and metrics related to Quality System processes</li><li>Support training initiatives related to Quality System requirements and compliance</li><li>Observe and enforce Quality Policy, Quality Manual, and Quality System Procedures</li><li>Provide guidance to various functional groups (Clinical Operations, Finance, IT, and more) to aid compliance</li><li>Keep stakeholders updated on progress, issues, and follow-up actions</li></ul><p><br></p><p>Qualities & Skills:</p><ul><li>Collaborative team player</li><li>Self-motivated, adaptable, and eager to contribute to collective goals</li><li>Personable and communicative — able to foster strong relationships</li><li>Ability to work effectively under pressure and manage competing priorities</li><li>Detail-oriented with strong organizational and time-management skills</li><li>Ability to make decisions with stakeholders’ perspectives in mind</li><li>Excellent written and verbal communication skills</li><li>Strong knowledge and understanding of ICH GCP</li><li>Familiar with applicable regulations (such as Health Canada Division 5 and FDA regulations)</li><li>Ability to solve problems creatively and independently</li><li>Willingness to travel as needed</li><li>Flexible and able to handle multiple tasks</li><li>Ability to remain productive and focused under pressure</li><li>Collaborative, team-oriented, and adaptable</li><li>Ability to apply common sense and a pragmatic approach to difficult problems</li></ul><p><br></p><p>Please apply here or send your cv to nfordyce@barringtonjames.com</p>
