[Remote] Director of Quality Assurance & Training, Early Phase Clinical Trials

Note: The job is a remote job and is open to candidates in USA. Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. The Director of Quality Assurance & Training, Early Phase Clinical Trials will lead U.S. quality operations, ensuring compliance with regulatory requirements and driving continuous improvement across operations in alignment with global standards.ResponsibilitiesLead U.S. Quality Assurance operations within the global Quality Management System (QMS), ensuring compliance with regulatory requirements and company standardsServe as the primary QA leader for U.S. operations, partnering with global teams to align quality processes and best practices across regionsMaintain inspection readiness and lead customer, sponsor, and regulatory audits, including FDA inspectionsOversee deviations, investigations, change controls, CAPAs, and root cause analysis to ensure timely resolution and sustainable corrective actionsMonitor quality metrics, identify trends and risks, and drive continuous improvement initiatives across operationsProvide QA guidance to Clinical Operations, laboratories, project teams, and other functional groups to support compliant execution of programsOversee training compliance, employee qualification programs, and workforce readiness for audits and inspectionsEnsure computerized systems compliance, including 21 CFR Part 11, data integrity, validation, and lifecycle management requirementsPartner with IT, Legal, and global stakeholders on data privacy, cross-border data transfer compliance, and evolving regulatory requirementsSupport Business Development through client audits, quality questionnaires, proposals, and capability presentationsMentor staff and promote a culture of quality, accountability, and operational excellenceManage QA priorities, resources, and cross-functional initiatives to meet business and compliance objectivesSkills10+ years of experience in clinical research, pharma, biotech, or CRO environments8+ years in QA / Quality Management leadership rolesProven success leading audits, inspections, CAPA, and enterprise compliance programsStrong knowledge of GxP, FDA expectations, and clinical quality systemsExperience operating in global or matrixed organizationsStrong executive presence and ability to influence senior stakeholdersExperience balancing strategic leadership with hands-on executionExcellent communication, coaching, and leadership skillsBenefitsInsurance including Medical, Dental & Vision with significant employer contributionsEmployer-funded Health Reimbursement AccountHealthcare & Dependent Care Flexible Spending Accounts100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance401k plan with generous employer matchAccess to an Employee Assistance ProgramCompany OverviewPharmaron is a contract research organization that offers research and development services for the life science industries. It was founded in 2004, and is headquartered in Beijing, Beijing, CHN, with a workforce of 10001+ employees. Its website is http://www.pharmaron.com.