Director, IT Quality & Compliance

Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. 
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary:
Vaxcyte is seeking an experienced, dynamic, and pragmatic professional to join our team as the Director of IT Quality and Compliance (QC). This role is tasked with supporting the Executive Director in managing and executing the organization's IT QC operational and project initiatives. This role will focus on the operational aspects of quality and compliance frameworks and industry best practices. The ideal candidate must possess a strong background in cloud compliance of regulated applications and demonstrate proven knowledge across a wide range of IT compliance requirements.  Expertise working in cloud-first IT environments is required.

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.

Reports to: Executive Director, IT, Quality, Security and Compliance Location: San Carlos, CA; Hybrid or Remote Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $227,000 – $264,000 (SF Bay Area). Salary ranges for non-California locations may vary.  Vaxcyte, Inc. 825 Industrial Road, Suite 300San Carlos, CA 94070 We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.