Associate Director, IT Quality, Security and Compliance (QSC)

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:
*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.
*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.
*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 Associate Director of IT Quality, Security and Compliance (QSC). This role is tasked with supporting the Executive Director in managing and executing the organization's IT QSC operational and project initiatives. This role will focus on the operational aspects of quality and compliance frameworks, the management and implementation of cybersecurity measures, and alignment with AI strategies to meet regulatory requirements 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:

• Support the implementation of IT Quality & Compliance and Cybersecurity strategic plans.
• Serve as the IT compliance reviewer for new system validations.
• Manage compliance reviews of GxP and SOX changes.
• Oversee the development, implementation, and revision of IT SOPs and policies.
• Develop quality metrics and performance indicators for IT projects, reporting on these to the Executive Director.
• Collaborate with various IT teams to ensure alignment of policies with technological advancements.
• Lead initiatives for IT colleague and end-user education and communication on IT quality, security, and compliance.
• Build, direct and mentor a dedicated team of 3rd party vendors focused on compliance, training, and IT security.
• Maintain an in-depth understanding of evolving industry standards and regulatory requirements, advising the Executive Director on necessary policy adjustments.
• Assist in effort to create and maintain an Enterprise Data Governance model.
• Assist in IT Vendor Management.
• Maintain IT compliance calendar (quarterly SOX reviews and GxP changes, for example).
• Manage periodic reviews of GxP applications.
• Report on key IT QSC metrics, presenting findings and recommendations to IT leadership and stakeholders.
• Drive identification and resolution of QSC-related issues. Work closely with relevant teams to implement corrective and preventive actions.
• Assist with implementation of data retention and legal hold solutions.
• Assist recurring cybersecurity initiatives including training, simulations, testing, and table-top exercises.
• Stay current with industry trends, emerging technologies, and best practices. Recommend their integration into the organization's quality strategies.
• Manage risk management processes and implement proactive measures to minimize vulnerabilities.
• Assist in managing incident response plan, coordinating rapid and effective responses to security incidents and breaches. Assist in investigations, root cause analyses, and remediation efforts.
• Assist with ongoing security awareness and training programs for employees, promoting a culture of security-conscious behavior throughout the organization.
• Collaborate with cross-functional teams to integrate compliance requirements into various IT initiatives, projects, and system implementations.
• Support regulatory audit activities when necessary.
• 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.
• Collaborate with legal, security, and risk management teams to ensure a cohesive and aligned approach to compliance and risk mitigation.

Requirements:

• Bachelor’s degree in information technology, compliance, or a related field; Master’s degree preferred.
• 3+ years of experience in a managerial role.
• Experience working with startup Life Science companies.
• Experience managing releases and validating GxP applications.
• Strong understanding and practice of IT methodologies, practices, and tools.
• 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 QSC 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.
• All Vaxcyte employees require vaccination against COVID-19.

Reports to: Executive Director, IT Quality, Security and Compliance Location: San Carlos, CA Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $201,000 – $209,000  Send resumes to: careers@vaxcyte.com 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.