Executive Director, Quality Enablement CPS

Fortrea•Dallas, TX

About The Position

The CPS organization is seeking a Senior Director or Executive Director, Quality Enablement to provide enterprise-level leadership in defining, governing, and advancing quality oversight across early-phase and pharmacology studies. This role is critical to shaping CPS quality strategy and positioning quality as a strategic differentiator for sponsors. Job Overview This executive leader partners closely with CPS Executive Leadership and key cross-functional stakeholders—including Clinic Operations, Project Management, Data & Analytics, Quality, and Technology—to embed Quality by Design (QbD) and proactive, risk-based quality management into CPS study delivery models. The Senior/Executive Director is accountable for ensuring that CPS operational processes, standards, and training programs are fit-for-purpose, scalable, and inspection-ready, while fully aligned with global regulatory expectations. This role drives a forward-looking quality enablement framework that supports innovation, accelerates early-phase development, and strengthens sponsor confidence. As a strategic advisor to senior leadership, this individual influences enterprise decision-making, leads change at scale, and ensures consistent, high-quality execution across CPS environments.

Requirements

Bachelor’s degree required; advanced degree preferred. Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.
10+ years of experience in clinical research, quality, or related fields (CRO, pharma, biotech).
5+ years of progressive leadership experience in, quality management or process improvements, preferably within early‑phase or clinical pharmacology environments.
Demonstrated experience leading global, cross‑functional CPS teams and influencing senior stakeholders.
Extensive sponsor‑facing experience, including executive‑level interactions.
Strong understanding of CPS study designs, clinic operations, and early‑phase regulatory expectations.
Proven experience with audits, inspections, CAPA, and quality governance.
Deep expertise in quality enablement and CPS study execution
Strong executive presence with the ability to influence without authority
Advanced data analytics and risk signal interpretation capability
Strategic leadership combined with strong operational execution
Excellent communication, presentation, and stakeholder management skills
Change leadership and organizational transformation capability
Strong business and financial acumen within a CRO/CPS environment

Responsibilities

CPS Quality Enablement Strategy & Governance Define and own the CPS‑specific quality enablement strategy, ensuring alignment with Fortrea enterprise quality standards and regulatory guidance (FDA, EMA, ICH E6/E8 R1).
Establish quality enablement governance models, standards, and operating procedures tailored to CPS study designs, clinic‑based execution, and early‑phase risk profiles.
Serve as the senior escalation point for CPS portfoliolevel quality risks, protocol complexity, data integrity concerns, and inspection readiness issues.
Portfolio Oversight & Quality Assurance Provide oversight of quality enablement execution across the CPS clinical trial portfolio, including first‑in-human, SAD/MAD, bioavailability, bioequivalence, and other clinical pharmacology studies.
Ensure consistent development, approval, and oversight of Integrated Quality Risk Management Plans (IQRMPs) strategies.
Review CPS‑level risk trends, KRIs, and performance indicators to drive proactive mitigation and continuous quality improvement.
Leadership & People Development Lead, coach, and develop quality enablement leaders and teams embedded within CPS, building sustainable capability across clinics and delivery teams.
Partner with CPS leadership on workforce planning, capability development, and succession planning related to quality and quality enablement roles.
Foster a culture of proactive risk ownership, accountability, and continuous improvement across CPS.
Cross‑Functional & Executive Partnership Act as a trusted advisor to CPS senior and executive leadership on quality enablement strategy, quality risk posture, and inspection readiness.
Collaborate with Clinic Operations, Project Management, Data Management, Biostatistics, Safety, and Quality to embed quality enablement into CPS delivery models.
Represent CPS in internal audits, sponsor audits, regulatory inspections, and governance forums.
Client Engagement & Business Development Serve as a senior CPS quality enablement representative in RFPs, RFIs, bid defenses, and sponsor governance meetings.
Articulate Fortrea’s CPS‑specific quality enablement value proposition, demonstrating differentiation in early‑phase quality oversight and execution.
Support complex sponsor discussions related to risk management, protocol complexity, data integrity, and inspection readiness.
Operational Excellence & Change Leadership Lead continuous improvement of CPS processes, tools, templates, and training materials.
Sponsor and lead change management initiatives to mature quality enablement adoption across CPS clinics and project teams.
Ensure CPS quality enablement knowledge management, lessons learned, and best practices are consistently captured and shared.