Title: QA Compliance Expert, Lead Location: Durham, NC Full time job requisition id REQ-10075908 Job Description Summary Step into a role where quality leadership directly shapes the future of gene therapies. As a QA Compliance Expert / Lead, you will be a trusted voice in ensuring that innovative medicines are developed and commercialized with the highest standards of quality, integrity, and compliance. Partnering closely with manufacturing, development, and global quality teams, you will lead critical quality system activities, mentor others, and drive meaningful improvements that safeguard patients and advance Novartis’ mission to reimagine medicine. Job Description Location: - This position will be located in Durham, NC and will be a hybrid role. - Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities: - Lead site quality system processes supporting development and commercialization of gene therapy medicines - Serve as subject matter expert for change control, nonconformance, and documentation programs - Drive consistent execution of investigations, root cause analysis, and corrective and preventive actions - Review and approve change controls and nonconformances in alignment with quality system requirements - Mentor and train quality assurance colleagues on quality system processes and best practices - Partner with manufacturing and operations on product‑related investigations and deviations - Own, author, and maintain standard operating procedures to ensure regulatory compliance - Monitor, analyze, and trend quality system metrics to identify improvement opportunities - Lead site forums and review boards supporting quality alignment and decision‑making - Support internal and external inspections as a quality system expert, ensuring readiness and compliance Essential Requirements: - Bachelor’s degree in a relevant scientific or technical discipline - Minimum eight years of quality assurance experience, including at least five years in pharmaceutical environments - Expert knowledge of quality systems, including change control and nonconformance management - Proven experience reviewing quality systems data to identify compliance and data consistency issues - Demonstrated expertise in data integrity principles and regulatory expectations - Advanced understanding of United States Food and Drug Administration and European Medicines Agency regulations - Hands-on experience authoring, reviewing, and owning standard operating procedures - Strong written and verbal communication skills, including technical writing proficiency Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $103,600 and $192,400 annually The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. #LI-Hybrid EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Salary Range $103,600.00 - $192,400.00 Skills Desired Collaboration, Communication Skills, Continuous Improvement mindset, Data Integrity, Dealing With Ambiguity, Decision Making, Digital saviness, Leadership, Problem Solving Skills, Project Management, Regulatory Requirements knowledge, Risk Management

Role Description As part of the QARA team, responsible for Post Market Surveillance (PMS) and Post Market Clinical Follow up (PMCF) activities for the assigned Natus Neuro Medical products. Primary responsibility of this position, but not exhaustive, is to uphold compliance to various regulations in relation to Post Market Surveillance, within the Natus Neuro Management System. - Define, write and edit PMS Plans/Reports, PMCF Plans/Reports to meet global regulatory requirements for each product family. - Schedule and lead PMS, PMCF meetings for each product. - Collect essential information and documents for Post Market Clinical Follow up, review for completeness and compliance with Standard Operating Procedures, associated protocols and appropriate regulations. - Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Clinical, Sales and Marketing, Quality Assurance and Risk Management and Regulatory Affairs). - Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment. - Support product development and design history files activities as per Quality Management System. - Stay up-to-date and follow all the Quality System procedures related to this job, which can affect the quality of products or services provided to our customers. - Participate in regulatory audits and defend PMS documentation and provide draft responses for questions from Notified Bodies. - All other duties assigned based on changing market conditions, company and business needs. Qualifications - Bachelor's degree in the health or life sciences. - 2-3 years of industry experience in the Medical Device field. - Post market surveillance report writing is essential. - Knowledge on EU MDR post market requirements. - Strong multi-tasking ability and must be able to transition to different priorities quickly and efficiently. - Possess a good working knowledge of regulatory industry standards such as QMSR, MDSAP, and EU MDR. Requirements - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. - Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Benefits - Generous compensation and benefits packages including health benefits. - 401k contribution. - 7 paid holidays + 2 floating holidays of your choosing. - Generous paid time off. - Tuition reimbursement assistance program. - Eligibility for performance-based bonuses or commissions, where applicable. Company Description Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals. Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency.

Role Description - Review requirements and user stories; provide actionable feedback - Create and maintain test plans, cases, and scenarios - Execute functional, regression, and exploratory tests - Perform mobile testing using Xcode, Android Studio, TestFlight, and AppTesters - Conduct API testing using Postman and cross-platform testing via BrowserStack - Monitor crashes and app performance using Embrace - Document bugs and test findings clearly - Use basic automation and debugging to support QA efforts - Work independently and manage workload efficiently - Excellent communication skills - Strong time and workload management skills - Can work with minimal supervision and under pressure Qualifications - Bachelor's degree in a related field - 7+ years of QA experience - Strong knowledge of QA methodologies and tools - Experience testing web, backend, iOS, and Android apps - Proficient in Postman, BrowserStack, Xcode, Android Studio, Embrace - Strong documentation, communication, and debugging skills Requirements - Nice to Have: ISTQB or similar certification - Experience with ClickUp, MoEngage, or fintech/banking system

• Support the PEC Training and QA Manager in developing the Quality Assurance (QA) program for our Patient Engagement Center (PEC). • Evaluate patient interactions, collect and analyze data to improve processes and protocols within the contact center. • Identify coaching opportunities and support PEC Managers in helping Patient Engagement Advocates improve their skills. • Monitor and conduct evaluations of interactions to assess the quality of service and identify strengths and areas for improvement in Advocate performance. • Support the “nesting” program when Advocates graduate training and begin handling interactions through more robust call monitoring. • Participate in cross-functional collaborations with other Ivy departments to ensure process alignment among the PEC, front office, and clinic teams. • Observe daily operations of the contact center and lead interaction quality calibrations to identify skill gaps and necessary training program improvements. • Help to improve PEC KPIs by sharing performance trends, areas of concern, and opportunities for improvement with Advocates and PEC management.