Digital Systems Validation Lead Chesterbrook, PA | Full-Time | Exempt At Novocure, we are patient-forward, aspiring to make a difference in cancer. Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy. WHAT YOU’LL DO <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Define and maintain the enterprise validation framework for digital and enterprise systems, including standards, procedures, and templates aligned with regulatory expectations</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Develop and apply risk-based validation strategies for new and existing systems in compliance with GxP, FDA, and internal quality requirements</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Lead the planning and oversight of verification and validation activities, including validation planning, test strategy definition, execution, and system acceptance</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Establish verification approaches, validation methods, and acceptance criteria, ensuring traceability from requirements through validation evidence</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Conduct risk-based assessments to determine the appropriate validation approach</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Define and maintain test strategies across digital systems and confirm execution of functional, integration, and system testing to demonstrate systems meet intended use</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Coordinate validation activities across the Enterprise Technology organization and ensure alignment with SDLC and release processes</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Ensure audit readiness and regulatory compliance through proper validation documentation and evidence</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Oversee development and approval of validation deliverables including Validation Plans, Test Plans and Protocols, DIOPQ protocols, Validation Reports, Traceability Matrices, and Validation Evidence packages</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Provide validation expertise during internal and external audits, maintain required documentation for inspections, and support remediation of validation gaps</li> </ul> ABOUT YOU <ul style="margin-top:0.0in;margin-bottom:0.0in" type="disc"> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Bachelor’s degree in Computer Science, Information Systems, Business, Engineering, or related field required; Master’s degree preferred</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">8+ years of experience in computer system validation within regulated industries such as healthcare, pharmaceutical, medical device, or life sciences</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Strong knowledge of GAMP 5, GxP regulations, SOX controls, 21 CFR Part 11, and FDA Computer Software Assurance (CSA)</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Proven ability to apply risk-based validation approaches across the system lifecycle</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Demonstrated expertise leading and coordinating validation activities across cross-functional teams supporting enterprise or digital systems</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Leadership experience managing and developing validation teams, governance frameworks, and scalable operating models</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Familiarity supporting FDA inspections, notified body reviews, and internal or external quality audits</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Understanding of SDLC and Agile development environments and how validation integrates within these processes</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Experience validating enterprise platforms such as ERP, QMS, CRM, data platforms, or cloud-based systems</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Strong understanding of CSV lifecycle concepts including IQ/OQ/PQ or equivalent lifecycle validation models</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Excellent communication skills to support audit responses, validation reviews, and regulatory discussions</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Knowledge of data platforms, APIs, and system integrations within validated environments</li> <li style="margin-top:5.0pt;margin-bottom:5.0pt;line-height:normal;margin-right:0.0in;font-size:11.0pt;font-family:Aptos, sans-serif">Ability to travel up to 20% as required</li> </ul> WHAT WE OFFER Novocure offers a competitive compensation and benefits package designed to support our employees and their families. The pay range which Novocure expects to pay for this role at the time of this posting is $116,000-130,000/yr. Compensation is based on a variety of factors including experience, education, job-related knowledge, and demonstrated skills. NOVOFLEX We offer a flexible, trust-based hybrid working model for most of our office-based roles. Employees are asked to be in the office three days per week. We understand that life is not always predictable, so if you need to adjust your schedule, such as leaving early or starting late occasionally, we trust you to balance your time in a way that works for both you and Novocure. ABOUT NOVOCURE Novocure is a company with a powerful mission: to extend the lives of people living with some of the most aggressive forms of cancer. Here your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you’ll connect, grow, and make a real difference. We’re a company with the drive of a startup and the strength that comes with 25 years of success. Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research work alongside engineering development of advanced technologies. This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers. Our patient-forward values – innovation – focus – drive – courage – trust – empathy Novocure is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veteran and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Novocure is committed to providing an interview process that is inclusive of our applicant’s needs. If you are an individual with a disability and would like to request an accommodation, please email <a href="mailto:[email protected]">[email protected]</a> If you're excited about this role, please apply. #LI-ER

Digital Systems Validation Lead (Wayne, PA, US, 19087) @ Novocure Inc

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