Sr. Manager, Validation, IT, Quality and Compliance

Company: Exokeryx
Location: San Carlos
Posted on: March 23, 2025

Job Description:

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 and proactive Senior Manager of Validation to lead validation activities for computerized systems, ensuring compliance with regulatory requirements and internal quality standards. This role is critical for maintaining GxP systems' validated state, supporting the organization's growth in a cloud-first IT environment, and ensuring the delivery of high-quality and compliant solutions across the enterprise.Essential Functions:

• Oversee Computer Software Assurance (CSA) and validation processes for new and existing computerized systems, ensuring alignment with GxP and 21 CFR Part 11 regulations.
• Manage and execute validation plans, protocols, and reports for IT systems, including a Tier 1 ERP, Quality Management Systems and other GxP systems.
• Collaborate with cross-functional teams to ensure validation requirements are integrated into project lifecycles and system implementations.
• Conduct risk assessments and validation impact analyses for changes to validated systems.
• Develop and maintain validation deliverables, such as Validation Master Plans, IQ/OQ/PQ protocols, and validation summary reports.
• Lead periodic reviews of validated systems to ensure ongoing compliance and performance optimization.
• Drive vendor qualification activities, including audits and assessments, to ensure compliance with Vaxcyte's Quality Management System (QMS).
• Ensure adherence to SOPs, policies, and regulatory guidelines while managing IT validation activities.
• Support internal and external audits by preparing and presenting validation documentation and responding to audit findings.
• Train and mentor teams on validation best practices and regulatory compliance requirements. 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 a related field (e.g., Information Technology, Computer Science, Engineering, or Life Sciences).
  • Master's degree preferred.
  • Minimum 8 years of experience in IT validation or a related field within the life sciences or pharmaceutical industry. Other combinations of education and/or experience may be considered.
  • Strong expertise in validating GxP systems, including Tier 1 ERP systems, such as SAP, Veeva, and LIMS, in a regulated environment.
  • Proven experience with CSA methodologies and risk-based validation approaches.
  • Knowledge of regulatory standards, including 21 CFR Part 11, Annex 11, and GAMP 5.
  • Experience conducting vendor assessments and managing audits.
  • Exceptional project management and organizational skills, with the ability to manage multiple validation projects simultaneously.
  • Strong analytical and problem-solving capabilities.
  • Excellent communication skills, both written and verbal, with the ability to work effectively with cross-functional teams.
  • Leadership and mentorship abilities to foster collaboration and compliance within teams.
  • Familiarity with Veeva Quality Systems or similar platforms.
  • Experience with automated testing tools and serialization.
  • Consulting or cross-functional project management background.Reports to: Executive Director, IT, Quality, Security and ComplianceLocation: San Carlos, CACompensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.Salary Range: $159,300 - $194,700 (SF Bay Area). Salary ranges for non-California locations may vary.Vaxcyte, Inc.825 Industrial Road, Suite 300San Carlos, CA 94070We 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.
    #J-18808-Ljbffr

Keywords: Exokeryx, San Francisco , Sr. Manager, Validation, IT, Quality and Compliance, IT / Software / Systems , San Carlos, California