Senior Director, Portfolio-level Quality Lead

Job Overview: Provide enterprise oversight and assurance that quality and compliance systems, processes, and performance meet applicable laws, regulations, SOPs, protocols, and sponsor/CRO requirements. Accountable for portfolio-level quality, reliability, inspection readiness, and risk posture across operations (US and International), driving consistent governance, prevention-focused quality strategy, and scalable quality systems. Summary of Responsibilities: Accountable for portfolio-level quality, reliability, and compliance risk outcomes; defines the target risk posture and drives measurable improvements in leading and lagging indicators. Provides direct line leadership for a portfolio/global quality team: sets strategy and priorities, establishes ways of working, and ensures delivery through effective performance management and coaching. Builds and evolves the operating model for portfolio quality (skills, capacity, supplier/partner leverage, and regional coverage) to scale impact while maintaining strong governance and compliance. Leads enterprise quality governance and decision forums (e.g., quality gates, release/readiness reviews, risk investment prioritization) to ensure consistent decisions and transparent trade-offs. Designs, implements, and continuously improves the Quality Operating System (metrics, dashboards, leading indicators, standard cadences, and executive reporting) to scale quality across the portfolio. Drives systemic prevention by identifying cross-portfolio root-cause themes, defining prevention strategies, and ensuring corrective/preventive actions translate into durable process and system changes. Sets enterprise standards and guardrails for processes, SOPs, working guidelines, and associated documentation; ensures alignment to regulatory expectations and sponsor requirements. Partners with Operations, Clinical, Data Management, Regulatory, and other functions to embed quality-by-design, risk-based approaches, and inspection readiness into operating models. Owns portfolio audit and inspection readiness strategy, including risk-based planning, prioritization, and oversight of execution through global/regional quality teams and contracted partners. Reviews and approves high-impact quality deliverables and risk acceptances; escalates significant quality/compliance risks to senior leadership with clear options and recommendations. Builds enterprise quality capability through standards, playbooks, and training programs, strengthening a culture of prevention and accountability. Represents Quality in senior leadership forums and with external stakeholders (sponsors and regulatory authorities) as needed, providing trusted guidance on compliance, quality systems, and risk posture. Qualifications (Minimum Required): Undergraduate degree (or international equivalent) in clinical, science, health-related field, or a licensed healthcare professional; advanced degree preferred. Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements. Strong knowledge of ICH GCP, FDA Code of Federal Regulations, and other applicable regulatory authority laws and guidelines. Proven experience setting and governing enterprise/portfolio quality systems (e.g., quality management systems, audit/inspection readiness frameworks, risk-based oversight). Experience designing and operating metrics, dashboards, leading indicators, and executive cadences to drive quality outcomes at scale. Demonstrated ability to influence across functions and levels, lead decision forums, and drive alignment in complex matrix environments. Proven direct line people leadership experience (hiring, performance management, talent development) with the ability to keep the team focused on strategic outcomes and scalable quality systems. Excellent organizational, interpersonal and communication skills; able to present to senior leadership and external stakeholders. Strong analytical and problem-solving skills, with experience leading cross-portfolio root cause analysis and prevention strategies. Experience partnering with sponsors and hosting/responding to sponsor audits and regulatory authority inspections (required). Experience in conducting systems and process audits and translating findings into sustained process and system improvements. At least 9 years Quality Assurance and ICH-GCP auditing experience (regional/global environment). Strong PC skills with Microsoft Word; proficient with MS Excel and MS PowerPoint; familiarity with EDC/RDC and data management systems preferred. Ability to read, write, and speak fluent English; willingness to travel as required. Strong knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical trial procedures Strong knowledge of ICH and local regulatory authority drug research and development regulations Knowledge of web-based communication tools for conferences Strong verbal and written communication and negotiation skills Ability to multitask and work effectively in a fast-paced environment with changing priorities Accountable, dependable and strong commitment; customer-service focused approach internally and externally Experience (Minimum Required): At least 9 years Quality Assurance and ICH-GCP auditing experience (regional/global environment). Physical Demands / Work Environment: Work Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying, or moving of objects, including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Pay Range: $220,000 – $236,000 USD Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. Application deadline - June 16, 2026 Learn more about our EEO & Accommodations request here. Apply To This Job