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

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