Director of Quality Engineering

Essential Responsibilities: Quality Engineering Leadership & People Development Lead, coach, mentor, and develop Quality Engineering and Validation professionals, including people leaders and technical individual contributors. Establish clear expectations, priorities, accountability, and development plans for the Quality Engineering organization. Assess organizational capabilities and resource requirements and build technical depth and succession within the function. Establish and execute Quality Engineering strategies, standards, policies, and processes aligned with business objectives and evolving regulatory expectations. Foster a culture of quality ownership, technical excellence, continuous improvement, accountability, and appropriate risk-taking. Serve as a senior Quality Engineering escalation point for complex technical, compliance, validation, and business issues. Computerized Systems, Equipment & Validation Provide leadership and technical oversight for the lifecycle of GxP computerized systems, laboratory systems, software, equipment, instrumentation, and supporting technologies. Establish and maintain scalable, risk-based approaches to Computer System Validation (CSV) and Computer Software Assurance (CSA) based on intended use, regulated process/data criticality, actual controls, and residual risk. Provide Quality oversight for systems including LIMS, ELN, eQMS, laboratory instrument software, equipment management systems, data platforms, integrations, and other GxP-relevant technologies. Ensure appropriate validation/qualification planning, requirements definition, risk assessment, testing, traceability, release, change management, periodic review, and retirement. Provide technical direction for equipment qualification, calibration, preventive maintenance, mapping, environmental monitoring systems, and associated quality events. Personally review, challenge, troubleshoot, and/or approve complex validation strategies and documentation when technical risk or business impact warrants Director-level involvement. Ensure validation and qualification approaches are scientifically sound, appropriately documented, risk-based, and scalable. AI, Digital Transformation & Emerging Technology Serve as a Quality leader and partner for our adoption of AI, machine learning, automation, digital workflows, and emerging technologies within regulated business and laboratory processes. Develop and implement risk-based assurance approaches for AI-enabled and automated systems based on context of use, GxP impact, data and model dependencies, probabilistic failure modes, human oversight, performance evaluation, change management, and ongoing monitoring. Partner with IT, business and laboratory stakeholders to translate emerging technologies into compliant and practical solutions. Evaluate technology and AI-related risks and determine appropriate Quality controls based on intended use, actual control architecture, potential impact to regulated data or decisions, and degree of human reliance; distinguish assistive uses from systems that generate or materially influence regulated results or decisions. Ensure AI and digital transformation initiatives maintain regulatory inspection readiness. Stay current with evolving regulatory expectations and industry practices surrounding AI, automation, computerized systems, and digital technologies in GxP environments. Large-Molecule CRO & Laboratory Quality Engineering Provide Quality Engineering leadership appropriate to a large-molecule bioanalytical CRO environment, where laboratory systems, instrumentation, scientific workflows, regulated data, and client requirements intersect. Develop a strong understanding of our laboratory workflows and ensure Quality Engineering practices enable reliable execution of regulated bioanalytical testing. Partner closely with scientific and laboratory leadership to understand operational requirements and appropriately balance compliance, scientific integrity, client commitments, speed, and business risk. Ensure Quality Engineering approaches account for the complexity and pace associated with supporting multiple sponsors, studies, laboratory platforms, and evolving analytical technologies. Provide quality oversight for laboratory technology implementations, instrument integrations, software upgrades, system changes, and other initiatives affecting regulated laboratory operations. Serve as a knowledgeable Quality Engineering representative during sponsor audits, regulatory inspections, and client discussions involving validated systems, laboratory equipment, data integrity, or technology. Quality Systems, Risk & Compliance Provide Quality Engineering oversight and support for the QMS/eQMS, including change controls, deviations, CAPAs, investigations, effectiveness checks, and related quality processes. Establish and promote effective Quality Risk Management practices, including risk identification, assessment, mitigation, escalation, and communication. Lead or support complex investigations involving computerized systems, equipment, data integrity, validation, automation, or technology. Identify systemic trends and recurring issues and drive sustainable corrective and preventive actions. Establish meaningful Quality Engineering metrics and dashboards to evaluate performance, risk, validation health, and improvement opportunities. Ensure compliance with applicable GxP regulations and predicate requirements, and appropriate use of relevant regulatory guidance and industry standards, including 21 CFR Part 11, applicable FDA/EMA/ICH/OECD guidance, EU Annex 11/15 where applicable, GAMP 5, and data integrity principles. Maintain inspection readiness and serve as a Quality Engineering SME during regulatory inspections, sponsor audits, internal audits, and vendor assessments. Lead remediation of significant Quality Engineering findings and ensure effective, sustainable resolution. Cross-Functional & Business Partnership Partner with Quality, Laboratory Operations, IT, Facilities/Engineering, Procurement and other stakeholders to embed Quality Engineering into technology and operational decisions early in the lifecycle. Provide pragmatic Quality guidance that enables the business to move quickly while maintaining appropriate compliance and risk controls. Influence senior leaders and technical teams on Quality Engineering priorities, risks, resource requirements, and investment decisions. Support vendor selection, qualification, assessment, and ongoing oversight for critical systems, equipment, technology, and services. Drive continuous improvement and simplification of Quality Engineering processes to improve efficiency and scalability without compromising compliance. Promote the use of data, metrics, root cause analysis, and structured problem-solving to move the organization from reactive issue management toward proactive risk reduction.

Additional Responsibilities: Other duties as assigned.

Minimum Preferred Qualifications: Education/

Experience: Bachelor's degree in Engineering, Life Sciences, Computer Science, Information Technology, or a related technical/scientific discipline required.10+ years of progressive experience in Quality Engineering, Validation, Quality Assurance, or a related function within pharmaceutical, biotechnology, CRO/CDMO, or another highly regulated life-sciences environment, or equivalent demonstrated technical and transformation depth. No less than 5 years of direct people leadership experience, preferably including leadership of managers and/or senior technical professionals. Significant hands-on experience with computerized system validation/assurance and sufficient knowledge of laboratory equipment qualification to provide effective Quality oversight. Demonstrated experience supporting GxP-regulated laboratory or scientific environments. Experience supporting regulatory inspections and sponsor/client audits. Experience leading significant quality, technology, digital, or organizational transformation initiatives. Demonstrated experience evaluating or implementing AI/ML, automation, advanced analytics, or other emerging technologies within a regulated environment. Experience within a CRO, bioanalytical laboratory, biologics/large-molecule organization, or similarly complex laboratory environment strongly preferred.

Skills: Deep knowledge of GxP regulations, predicate requirements, regulatory guidance, and industry standards applicable to computerized systems, laboratory equipment, validation/assurance, and data integrity, with demonstrated ability to distinguish binding requirements from guidance, contractual obligations, and internal policy. Advanced knowledge of CSV, CSA, GAMP 5, system lifecycle principles, risk-based assurance, 21 CFR Part 11, and applicable data integrity expectations; familiarity with relevant FDA/EMA/ICH/OECD guidance and EU Annex 11/15 where applicable. Understanding with modern laboratory and enterprise technology, including LIMS, ELN, eQMS, instrument software, cloud/SaaS architectures, APIs and integrations, databases and data pipelines, Agile/Dev Ops/CI/CD, automated testing, configuration management, and production monitoring, sufficient to evaluate architecture, controls, and assurance evidence; hands-on engineering execution is not required. Ability to understand scientific and laboratory workflows sufficiently to evaluate Quality and compliance risk within a bioanalytical CRO.Technical fluency in AI/ML and generative AI sufficient to evaluate context of use, architecture, model and data dependencies, probabilistic failure modes, performance evaluation, human oversight, monitoring, and change controls in regulated environments; model development or training expertise is not required. Demonstrated ability to translate regulatory requirements and guidance into practical, risk-proportionate business solutions. Strong technical problem-solving, investigation, root cause analysis, and risk management capability. Demonstrated ability to lead organizational change and modernize established Quality processes. Strong project/program management and prioritization skills. Ability to communicate complex technical and regulatory concepts effectively to scientists, technologists, Quality professionals, clients, auditors, and senior executives. Strong judgment and ability to make risk-based decisions in a fast-paced, client-driven environment. Ability to balance strategic leadership with direct hands-on involvement when business or compliance risk requires it. Preferred Credentials Advanced degree preferred Supervisory Responsibility Directly and/or indirectly leads Quality Engineering and Validation personnel, potentially including: Associate Director / Senior Manager Manager Senior Quality/Validation Engineers Quality/Validation Engineers I & IIOther Quality Engineering professionals as assigned Supervision Received Minimal supervision and instruction. Exercises significant independent judgment and discretionary authority. Expected to serve as the senior technical and functional authority for assigned Quality Engineering programs. Working Environment Based in Durham, North Carolina. Office and laboratory/clinical environment. Exposure to biological fluids with potential exposure to infectious organisms Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets Potential exposure to skin and lung irritants, toxic materials, and hazardous waste Exposure to fluctuating temperatures on rare occasions

Physical Demands: Ability to work in an upright and/or stationary position for up to eight (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 to operate office equipment Frequent mobility needed Frequent crouching, stooping, with frequent bending and twisting of upper body and neck Light to moderate lifting and carrying (or otherwise moves) objects, including laboratory equipment, laboratory supplies, and laptop computer, with a maximum lift of 20 pounds Ability to access and use a variety of computer software Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences Frequently interacts with others to obtain or relate information to diverse groups Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence Ability to perform under stress and multi-task Regular and consistent attendance Position Type and Expected Hours of Work This is a full-time position Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the Employee Handbook Occasional weekend, holiday, and evening work required