[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.
Responsibilities
- Lead U.S. Quality Assurance operations within the global Quality Management System (QMS), ensuring compliance with regulatory requirements and company standards
- Serve as the primary QA leader for U.S. operations, partnering with global teams to align quality processes and best practices across regions
- Maintain inspection readiness and lead customer, sponsor, and regulatory audits, including FDA inspections
- Oversee deviations, investigations, change controls, CAPAs, and root cause analysis to ensure timely resolution and sustainable corrective actions
- Monitor quality metrics, identify trends and risks, and drive continuous improvement initiatives across operations
- Provide QA guidance to Clinical Operations, laboratories, project teams, and other functional groups to support compliant execution of programs
- Oversee training compliance, employee qualification programs, and workforce readiness for audits and inspections
- Ensure computerized systems compliance, including 21 CFR Part 11, data integrity, validation, and lifecycle management requirements
- Partner with IT, Legal, and global stakeholders on data privacy, cross-border data transfer compliance, and evolving regulatory requirements
- Support Business Development through client audits, quality questionnaires, proposals, and capability presentations
- Mentor staff and promote a culture of quality, accountability, and operational excellence
- Manage QA priorities, resources, and cross-functional initiatives to meet business and compliance objectives
Skills
- 10+ years of experience in clinical research, pharma, biotech, or CRO environments
- 8+ years in QA / Quality Management leadership roles
- Proven success leading audits, inspections, CAPA, and enterprise compliance programs
- Strong knowledge of GxP, FDA expectations, and clinical quality systems
- Experience operating in global or matrixed organizations
- Strong executive presence and ability to influence senior stakeholders
- Experience balancing strategic leadership with hands-on execution
- Excellent communication, coaching, and leadership skills
Benefits
- Insurance including Medical, Dental & Vision with significant employer contributions
- Employer-funded Health Reimbursement Account
- Healthcare & Dependent Care Flexible Spending Accounts
- 100% Employer-paid Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
- 401k plan with generous employer match
- Access to an Employee Assistance Program
Company Overview