Director – IT Quality & Compliance

Essential Functions:

• Lead and support Computer Software Assurance (CSA) activities for new and existing systems, ensuring compliance with GxP standards and 21 CFR Part 11 regulations​​.
• Assess and manage IT GxP Change Controls, ensuring proper impact assessment, testing, and documentation for any system modifications​​. Monitor and validate IT system changes using defined change control processes.
• Assess and manage IT risks, implementing strategies to mitigate vulnerabilities.
• Oversee the development, implementation, and revision of IT SOPs and policies.
• Evaluate and qualify IT vendors for GxP systems using standardized assessment procedures, including vendor audits and the GxP Software Provider Questionnaire​​.
• Lead the development of Vaxcyte processes for IT Quality, Compliance, and Cybersecurity.
• Oversee vendor compliance with Vaxcyte's Quality Management System (QMS) and regulatory standards​.
• Conduct IT vendor evaluations, ensuring compliance with Vaxcyte’s Vendor Management Program.
• Lead internal, external and regulatory audits for IT by preparing and presenting required documentation.
• Lead initiatives for IT colleague and end-user education and communication on IT quality, security, and compliance.
• Collaborate with various IT teams to ensure alignment of policies with technological advancements.
• Maintain an in-depth understanding of evolving industry standards and regulatory requirements, advising the Executive Director on necessary policy adjustments.
• Manage periodic reviews of GxP applications to verify their validated state and identify areas for improvement.
• Collaborate with cross-functional teams to integrate compliance requirements into various IT initiatives, projects, and system implementations.
• Monitor and evaluate changes in regulations and standards that could impact IT compliance, and work with the appropriate teams to implement necessary adjustments.
• Conduct periodic audits, assessments, and internal reviews to validate the effectiveness of IT compliance measures and identify areas for improvement.
• Report on key IT QC metrics, providing actionable insights to leadership.
• Drive identification and resolution of QC-related issues. Work closely with relevant teams to implement corrective and preventive actions.
• Lead IT quality and compliance training programs to ensure regulatory awareness and adherence across teams.
• Develop and implement training materials for IT and business teams.

Requirements:

• Bachelor’s degree in information technology, compliance, or a related field; Master’s degree preferred, with a minimum of 12 years of experience. Other combinations of education and/or experience may be considered. 5+ years of experience in a managerial role.
• Experience working with startup Life Science companies.
• Experience with Veeva Quality Systems mandatory.
• Experience managing releases and validating GxP applications.
• Strong understanding and practice of IT methodologies, practices, and tools.
• Experience validating ERP systems.
• Experience implementing / managing automated testing tools (suggested).
• Experience with serialization.
• Experience in developing policies around data privacy
• Familiarity with regulatory standards and their application within IT organizations.
• Experience managing and motivating blended teams (full-time, matrix, 3rd party).
• Strong experience in managing projects and delivering to strict deadlines.
• Analytical mindset with the ability to identify patterns, trends, and potential areas of improvement.
• Exceptional business partnering skills. Consulting background a strong plus.
• Experience with Quality and Compliance frameworks and standards and their practical application within IT organizations.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with technical and non-technical stakeholders.