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Executive Director, Quality Enablement CPS
Location
United States
Posted
58 days ago
Salary
0
Seniority
Lead
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Job Description
Executive Director, Quality Enablement CPS
Fortrea
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. . 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. Learn more about our EEO & Accommodations request here.
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Recruitment Fraud Alert We’ve learned that scammers are impersonating Commvault team members—including HR and leadership—via email or text. These bad actors may conduct fake interviews and ask for personal information, such as your social security number. What to know: - Commvault does not conduct interviews by email or text. - We will never ask you to submit sensitive documents (including banking information, SSN, etc) before your first day. If you suspect a recruiting scam, please contact us at wwrecruitingteam@commvault.com About Commvault Commvault (NASDAQ: CVLT) is the gold standard in cyber resilience. The company empowers customers to uncover, take action, and rapidly recover from cyberattacks – keeping data safe and businesses resilient. The company’s unique AI-powered platform combines best-in-class data protection, exceptional data security, advanced data intelligence, and lightning-fast recovery across any workload or cloud at the lowest TCO. 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Reflected below is the minimum and maximum base salary range for this role. At Commvault we use broad salary ranges in our job postings to reflect the diverse levels of expertise and experience among our candidates and is not reflective of the total compensation and benefits package. The specific salary offered will be determined based on your unique qualifications, including your relevant experience, skills, and the value you bring to the role. While the range provides a general idea of the compensation, it is important to note that placements within the range are not automatic and will be carefully considered to ensure a fair and competitive offer. We are committed to rewarding talent and experience. Pay Range $168,300—$270,250 USD Commvault is an equal opportunity workplace and is an affirmative action employer. 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