Director of Quality Assurance & Training

Pharmaron • Piscataway Township, NJ

1d • Remote

About The Position

Pharmaron is seeking an experienced and hands-on Director of Quality Assurance & Compliance to lead U.S. quality operations and serve as a key member of the Global Quality organization. This high-impact leadership role is responsible for maintaining a strong state of inspection readiness, ensuring effective quality systems execution, and driving continuous improvement across U.S. operations in alignment with global standards.
The Director will oversee core Quality Assurance functions including audits, regulatory inspections, CAPA management, training compliance, computerized system compliance, and risk-based quality initiatives. This leader will also partner closely with cross-functional teams including Clinical Operations, IT, Legal, Business Development, and global QA stakeholders to ensure consistent, efficient, and compliant business practices.

Requirements

• 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

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees