Associate Director of QA Computer Systems

Accountabilities:

• • Lead validation planning, execution, and documentation for new and existing computerized systems, including EDMS, QMS, ERP, and RIM platforms.
  • Create, execute, and approve validation deliverables such as validation plans, risk assessments, user and system requirements, test scripts, traceability matrices, and validation summary reports.
  • Maintain the validated state of QA computer systems through ongoing documentation, system reviews, lifecycle management, and quality oversight.
  • Identify opportunities to streamline, standardize, and scale computer system validation processes while maintaining appropriate regulatory controls.
  • Ensure data integrity principles are consistently incorporated into computerized system processes and validation activities.
  • Support vendor qualification, audits, inspections, and other activities required to demonstrate system compliance and quality.
  • Lead ongoing system lifecycle activities, including risk assessments, change controls, audits, periodic reviews, and remediation activities.
  • Manage applicable vendor contracts and software licensing for computerized systems.
  • Partner with IT to improve system functionality and the end-user experience while maintaining compliance requirements.
  • Work closely with cross-functional stakeholders to understand business and regulatory needs and ensure systems effectively support organizational objectives.
  • Support inspection readiness by maintaining accurate validation and system documentation and preparing relevant materials and presentations.
  • Contribute to quality and validation strategies as business and system requirements evolve during the transition from clinical development to commercial operations.

  Requirements:

  • Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field, or equivalent professional experience.
  • 10+ years of experience in computer system validation within regulated industries, with strong knowledge of validation methodologies, tools, and industry best practices.
  • Strong understanding of applicable regulatory requirements and guidelines, including FDA 21 CFR Part 11, GAMP 5, EU/EMA GMP Annex 11, and broader GxP requirements.
  • Proven experience in quality assurance, computer system validation, software testing, or IT quality within the life sciences industry.
  • Demonstrated experience with Veeva Vault and Veeva Systems applications, including validation, quality assurance, or implementation activities.
  • Knowledge of software development lifecycle (SDLC) methodologies and their application to regulated computerized systems.
  • Strong analytical, problem-solving, and decision-making skills, with a high level of attention to detail and commitment to accuracy and quality.
  • Excellent communication and collaboration skills, with the ability to work effectively across QA, IT, Clinical, Commercial, Finance, vendors, and other stakeholders.
  • Experience working with multiple GxP systems and system implementations is preferred.
  • Experience managing employees and contractors is a plus.
  • Veeva Vault Administrator certification or similar credentials is preferred.
  • Experience with electronic validation management is advantageous.
  • Ability to adapt effectively within a fast-paced and evolving biotechnology environment.
  • Proficiency with SharePoint, Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
  • Ability to travel up to 15% of the time.

  Benefits:

  • Remote work opportunity.
  • Base salary range of $170,000–$200,000, with compensation dependent in part on geographic location, qualifications, education, experience, and market factors.
  • Eligibility for an annual performance bonus based on applicable plan terms and company and individual performance.
  • Medical, dental, and vision insurance.
  • Disability, life, and long-term care insurance.
  • Holiday pay.
  • Flexible vacation program.
  • 401(k) plan with company matching contributions.
  • Educational assistance benefit.
  • Fitness center reimbursement.
  • Equal opportunity employment and reasonable consideration for qualified applicants regardless of protected characteristics.