Director, Software Quality and Compliance Join to apply for the Director, Software Quality and Compliance role at Labviva

Please make an application promptly if you are a good match for this role due to high levels of interest. Director, Software Quality and Compliance Join to apply for the Director, Software Quality and Compliance role at Labviva Direct message the job poster from Labviva We are seeking a strategic and detail-oriented Director of Software Quality and Compliance to lead our quality assurance (QA), software validation, and regulatory compliance efforts. This role will be responsible for ensuring that our platform and development processes meet pharmaceutical industry standards (e.g., GxP, 21 CFR Part 11, and other relevant regulatory frameworks) while aligning with modern software development practices. Key Responsibilities Software Quality Leadership Define and lead the software quality strategy for the organization across all products and services. Build and manage a high-performing QA team (manual, automation, and validation specialists). Ensure implementation of scalable testing frameworks including unit, integration, regression, and performance testing. Develop metrics to track software quality and drive continuous improvement. Compliance & Regulatory Management Maintain and enhance quality systems to ensure compliance with relevant pharmaceutical regulations, such as: 21 CFR Part 11 GAMP 5 GxP requirements (Good Automated Manufacturing Practice) Oversee Computer System Validation (CSV) efforts for all regulated software features. Collaborate with Engineering, Product, Legal, and Commercial teams to ensure cross-functional alignment. Process Development & Auditing Establish and enforce software development lifecycle (SDLC) practices compliant with industry standards (e.g., ISO 9001, ISO/IEC 27001). Prepare and support internal and external audits (e.g., customer, regulatory, ISO, or FDA). Document SOPs, work instructions, and validation protocols. Cross-Functional Collaboration Act as the key liaison between engineering, product, and commercial teams. Provide compliance-related input during product design and risk analysis. Partner with DevOps to ensure traceability, version control, and release documentation align with validation requirements. Qualifications Required Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or related field. 8+ years of experience in software quality assurance, with at least 3 years in a leadership role. Demonstrated experience with regulatory compliance in life sciences or pharmaceutical domains. Deep knowledge of software validation, risk management, and QA in regulated environments. Preferred Experience with SaaS platforms, cloud-native environments, and Agile/DevOps practices. Familiarity with tools such as Jira, TestRail, Jenkins, Selenium, GxP documentation platforms. Certifications such as ASQ Certified Software Quality Engineer (CSQE), CISA, or similar are a plus. Seniority level Seniority levelDirector Employment type Employment typeFull-time Job function Job functionQuality Assurance IndustriesSoftware Development Referrals increase your chances of interviewing at Labviva by 2x Sign in to set job alerts for “Director of Software” roles. Greater Boston $230,000.00-$270,000.00 2 weeks ago Director of Embedded Software EngineeringDirector, Software Engineering Global, Converse Watertown, MA $200,000.00-$225,000.00 1 day ago Boston, MA $160,000.00-$200,000.00 3 weeks ago Software Engineering Manager, Infrastructure Boston, MA $177,000.00-$251,000.00 2 days ago Boston, MA $200,000.00-$250,000.00 2 weeks ago Senior Director of Software Engineering- Warehouse Robotics Waltham, MA $160,000.00-$185,000.00 1 month ago Boston, MA $180,000.00-$220,000.00 5 months ago Boston, MA $174,500.00-$274,230.00 1 month ago Waltham, MA $200,000.00-$240,000.00 1 week ago Boston, MA $174,500.00-$274,230.00 2 weeks ago Software Engineering Manager, Motion PlanningVice President, Solution Engineering - Digital Boston, MA $278,320.00-$372,330.00 4 days ago Boston, MA $219,000.00-$350,000.00 4 days ago Cambridge, MA $294,000.00-$414,000.00 5 days ago Software Engineering Manager - Image ProcessingHead of Engineering, Investment Data SystemsSoftware Engineering Manager (Healthcare) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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