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Director, Software Quality and Compliance

Headquarters

About the Role

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.

About the Company

Labviva is on a mission to accelerate the pace of life science research. We connect researchers with suppliers of reagents, chemicals and instrumentation in an intuitive user-friendly platform that supports the priorities of scientists while staying compliant with purchasing rules.

We are a venture-funded start-up that acknowledges that the unique contributions of each team member drive our success. We commit to creating a diverse and inclusive workspace where people can make a positive impact. At Labviva, we invest in our employees and strongly believe that a culture of respect and support drives success for all involved.

We provide a competitive set of benefits including but not limited to a hybrid – office/remote work option, health benefits, discretionary time off, parental leave, competitive salary and equity, and Thursday company lunches.

We are an equal opportunity employer and building a diverse team is our top priority. At Labviva, we celebrate all. Help us build an inclusive community that will transform the life sciences industry. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics as outlined by federal, state or local laws, regulations, or ordinances.

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