Director of Quality Assurance & Training, Early Phase Clinical Trials

Director of Quality Assurance & Training, Early Phase Clinical Trials

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more, visit

Pharmaron is seeking an experienced and hands-on Director of Quality Assurance & Training, Early Phase Clinical Trials 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.

Key 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.

What We're Looking For

• 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

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• 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

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.