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Labviva

Director, Software Quality and Compliance

Labviva, Boston

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Director, Software Quality and Compliance

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

Director, Software Quality and Compliance

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

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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 level

    Director

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Quality Assurance

  • Industries

    Software Development

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