Executive Director, Quality Enablement CPS

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Summary of 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.

Qualifications (Minimum Required):

• Bachelor’s degree required; advanced degree preferred.
• Fortrea may consider relevant and equivalent experience and successful project outcomes in lieu of educational requirements.

Experience/Skills (Minimum Required):  

• 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

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.

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