PAREXEL International
Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. This role will work within our innovative Data & Technology group that continues to evolve to meet business needs, fuel Parexel's growth and enable improved support for stakeholders, including customers and ultimately patients, who will benefit from Parexel's integrated processes and systems. This role can be based in the UK, Poland or Romania and can be fully home based. As the Executive Director, Systems Quality, Validation & Processes you will be the senior leader responsible for establishing and overseeing Parexel's global technology quality lifecycle, computerized system validation (CSV), and process governance across all Data & Technology (D&T) solutions. You will ensure that all systems-particularly those impacting clinical development, safety, regulatory, and enterprise operations-adhere to GxP expectations, global regulatory standards, and internal quality frameworks. You will provide enterprise level leadership to ensure "audit ready" consistent system validation practices, optimized processes, and strong collaboration between technology, business, quality, and compliance stakeholders. Key Responsibilities & What You'll Do: Systems Quality & Compliance Leadership Define and lead the enterprise-wide technology quality strategy, ensuring alignment with GxP expectations, ICH, EMA, FDA, and internal quality policies. Govern compliance with the Technology SOPs Ensure systems remain in a validated and audit ready state throughout their lifecycle, including upgrades, changes, integrations, and decommissioning. Computerized System Validation (CSV) Governance & Oversight Oversee lifecycle validation activities for all D&T systems, enabling a risk based, scalable, automated validation program Lead the enterprise validation framework-including planning, risk assessments, requirements, testing, traceability, reporting, and periodic review. Govern validation team roles (System Owner, Business Analyst, Technology Representative, Validation Representative, Quality Representative, SME) Drive standardization of validation documentation, templates, and tools across all technology domains. Process Optimization, Standards & Governance Lead the definition, deployment, and continuous improvement of technology delivery processes (SDLC, change management, testing, documentation, release management). Ensure cross functional alignment between D&T, Quality, Compliance, Clinical Operations, Safety, and Regulatory. Serve as the executive owner of validation policy updates and procedural improvements. Test Strategy, Execution, Quality Engineering & Tooling Enablement Oversee and execute functional, automated, regression, integration, smoke, and user acceptance testing activities Promote continual improvement and automation capabilities that reduce validation burden while improving consistency and traceability. Establish enterprise standards for test evidence, defect management, and quality metrics Vendor, System, and Risk Management Govern the process for reviewing vendor validation packages, reliance strategies, and partner oversight Ensure all third party systems meet Parexel's quality and validation expectations. Lead risk based decision making frameworks for validation effort, documentation rigor, and mitigation plans. Cross Functional Partnership & Strategic Alignment Collaborate with D&T and business executive leadership, Data Governance to ensure cross functional integration of quality and validation standards. Ensure alignment with broader D&T organizational strategies and roadmaps Partner closely with Clinical, Safety, Regulatory, and Operational groups to ensure their systems maintain compliance during rapid change. Team Leadership & Talent Development Lead a global team across system quality assurance, validation engineering, process governance, and compliance. Establish competency frameworks aligned with skills in D&T Quality & Validation functions Promote a culture of accountability, precision, continuous improvement, and proactivity in compliance. Education Bachelor's degree in Computer Science, Engineering, Life Sciences, Quality Engineering, or related field required. Master's degree or equivalent experience preferred. Skills Deep expertise in GxP system validation, computerized system lifecycle management, and global regulatory requirements. Strong understanding of testing methodologies, validation frameworks, and risk based quality approaches. Exceptional leadership skills with ability to influence across technology, quality, and business groups. Highly skilled in process design, optimization, SDLC governance, and audit readiness. Strong analytical, documentation, and problem solving capabilities. Knowledge and Experience Very strong Senior Director or Executive Director level experience in technology quality assurance, software validation, regulatory compliance, or related disciplines. Proven experience leading global quality and validation programs across complex system landscapes. Deep familiarity with validation documentation standards and roles Experience with test management tools, automated testing platforms, and enterprise quality systems. Experience supporting clinical, safety, regulatory, or GxP relevant enterprise systems strongly preferred. In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and in return for your hard work you will be rewarded with a competitive base salary, bonus, company car or car allowance, holiday as well as other leading benefits you would expect with a top company in the CRO Industry. Apply today to begin your Parexel journey!
Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. This role will work within our innovative Data & Technology group that continues to evolve to meet business needs, fuel Parexel's growth and enable improved support for stakeholders, including customers and ultimately patients, who will benefit from Parexel's integrated processes and systems. This role can be based in the UK, Poland or Romania and can be fully home based. As the Executive Director, Systems Quality, Validation & Processes you will be the senior leader responsible for establishing and overseeing Parexel's global technology quality lifecycle, computerized system validation (CSV), and process governance across all Data & Technology (D&T) solutions. You will ensure that all systems-particularly those impacting clinical development, safety, regulatory, and enterprise operations-adhere to GxP expectations, global regulatory standards, and internal quality frameworks. You will provide enterprise level leadership to ensure "audit ready" consistent system validation practices, optimized processes, and strong collaboration between technology, business, quality, and compliance stakeholders. Key Responsibilities & What You'll Do: Systems Quality & Compliance Leadership Define and lead the enterprise-wide technology quality strategy, ensuring alignment with GxP expectations, ICH, EMA, FDA, and internal quality policies. Govern compliance with the Technology SOPs Ensure systems remain in a validated and audit ready state throughout their lifecycle, including upgrades, changes, integrations, and decommissioning. Computerized System Validation (CSV) Governance & Oversight Oversee lifecycle validation activities for all D&T systems, enabling a risk based, scalable, automated validation program Lead the enterprise validation framework-including planning, risk assessments, requirements, testing, traceability, reporting, and periodic review. Govern validation team roles (System Owner, Business Analyst, Technology Representative, Validation Representative, Quality Representative, SME) Drive standardization of validation documentation, templates, and tools across all technology domains. Process Optimization, Standards & Governance Lead the definition, deployment, and continuous improvement of technology delivery processes (SDLC, change management, testing, documentation, release management). Ensure cross functional alignment between D&T, Quality, Compliance, Clinical Operations, Safety, and Regulatory. Serve as the executive owner of validation policy updates and procedural improvements. Test Strategy, Execution, Quality Engineering & Tooling Enablement Oversee and execute functional, automated, regression, integration, smoke, and user acceptance testing activities Promote continual improvement and automation capabilities that reduce validation burden while improving consistency and traceability. Establish enterprise standards for test evidence, defect management, and quality metrics Vendor, System, and Risk Management Govern the process for reviewing vendor validation packages, reliance strategies, and partner oversight Ensure all third party systems meet Parexel's quality and validation expectations. Lead risk based decision making frameworks for validation effort, documentation rigor, and mitigation plans. Cross Functional Partnership & Strategic Alignment Collaborate with D&T and business executive leadership, Data Governance to ensure cross functional integration of quality and validation standards. Ensure alignment with broader D&T organizational strategies and roadmaps Partner closely with Clinical, Safety, Regulatory, and Operational groups to ensure their systems maintain compliance during rapid change. Team Leadership & Talent Development Lead a global team across system quality assurance, validation engineering, process governance, and compliance. Establish competency frameworks aligned with skills in D&T Quality & Validation functions Promote a culture of accountability, precision, continuous improvement, and proactivity in compliance. Education Bachelor's degree in Computer Science, Engineering, Life Sciences, Quality Engineering, or related field required. Master's degree or equivalent experience preferred. Skills Deep expertise in GxP system validation, computerized system lifecycle management, and global regulatory requirements. Strong understanding of testing methodologies, validation frameworks, and risk based quality approaches. Exceptional leadership skills with ability to influence across technology, quality, and business groups. Highly skilled in process design, optimization, SDLC governance, and audit readiness. Strong analytical, documentation, and problem solving capabilities. Knowledge and Experience Very strong Senior Director or Executive Director level experience in technology quality assurance, software validation, regulatory compliance, or related disciplines. Proven experience leading global quality and validation programs across complex system landscapes. Deep familiarity with validation documentation standards and roles Experience with test management tools, automated testing platforms, and enterprise quality systems. Experience supporting clinical, safety, regulatory, or GxP relevant enterprise systems strongly preferred. In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and in return for your hard work you will be rewarded with a competitive base salary, bonus, company car or car allowance, holiday as well as other leading benefits you would expect with a top company in the CRO Industry. Apply today to begin your Parexel journey!