Job FunctionsOverseeing computer software assurance and validation processesManaging and executing validation plans, protocols, and reportsConducting risk assessments and validation impact analysesDeveloping and maintaining validation deliverablesLeading periodic reviews of validated systemsDriving vendor qualification activitiesEnsuring adherence to SOPs, policies, and regulatory guidelines
Job RequirementsBachelor’s degree in a related field (e.g., Information Technology, Computer Science, Engineering, or Life Sciences)Minimum 8 years of experience in IT validation or a related field within the life sciences or pharmaceutical industryStrong analytical and problem-solving capabilitiesExcellent communication skills, both written and verbal
SkillsStrong expertise in validating GxP systemsProven experience with CSA methodologies and risk-based validation approachesKnowledge of regulatory standards, including 21 CFR Part 11, Annex 11, and GAMP 5Experience conducting vendor assessments and managing auditsExceptional project management and organizational skillsStrong analytical and problem-solving capabilitiesExcellent communication skills, both written and verbalLeadership and mentorship abilities to foster collaboration and compliance within teamsFamiliarity with Veeva Quality Systems or similar platformsExperience with automated testing tools and serializationConsulting or cross-functional project management background
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 Compliance Location: 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.Apply for this job
Life at Vaxcyte
Thrive Here & What We ValueCourageously make the most complex biologics ever attempted to protect humankind | Model excellence with a shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Models our Core Values: is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.</s> | Rethink convention | Aim high | Lead with heart | Model excellence</s> | Vaxcyte is committed to protecting humankind from bacterial diseases through high-fidelity vaccines. | The company values creativity and intellectual diversity in all aspects of its work. | Vaxcyte aims to make the most complex biologics ever attempted to protect humankind. | The company leads with kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | Vaxcyte models excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision-making.</s> | 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.</s> | AIM HIGH: Embody 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 business objectives. | RETHINK CONVENTION: Bring creative and intellectual diversity to every facet of work done in order to innovate and re-innovate the way vaccines are delivered. | MODEL EXCELLENCE: Demonstrate integrity, accountability, equality and clarity across communications and decision making.</s> | AIM HIGH: Courageously make the most complex biologics ever attempted to protect humankind. | LEAD WITH HEART: Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | RETHINK CONVENTION: Creative and intellectual diversity to every facet of work done in order to innovate and re-innovate the way vaccines are delivered. | MODEL EXCELLENCE: Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Collaborative role working closely with the Supply Chain team to deliver a system that will support Vaxcyte's growth through commercialization. | Promote a culture of continuous improvement by identifying areas for enhancement and implementing best practices in SAP and APS program management.</s> | Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making</s> | Kindness-first approach to collaboration and vigorous debate that advances business objectives | Vaxcyte's mission is to protect humankind from bacterial diseases, which have serious and costly health consequences when left unchecked. | The company values rethinking convention, aiming high, leading with heart, and modeling excellence in their work. | They prioritize collaboration across teams and strive for process improvement initiatives to enhance efficiency and compliance.</s> | 1. RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and reinnovate the way vaccines are delivered | 2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind | 3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindnessfirst, inclusive approach to collaboration and vigorous debate that advances our business objectives | 4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making</s> | Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases | Our work together is guided by four enduring core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE | 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.</s> | Bringing creative and intellectual diversity to every facet of the work done in order to innovate and re-innovate the way vaccines are delivered</s> | Join our mission to protect humankind from the consequences of bacterial diseases | Collaborate with various stakeholders to understand integration requirements and translate them into technical solutions | Stay up to date with the latest trends and technologies in integration, particularly within the Workato ecosystem | Participate in code reviews and ensure the quality of integration solutions | Proactively identify and address potential integration challenges | Manage and prioritize integration projects, ensuring timely delivery and within budget</s> | Shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making | 11. RETHINK CONVENTION: Creative and intellectual diversity in every aspect of work | 12. AIM HIGH: Courageously make the most complex biologics ever attempted to protect humankind | 13. LEAD WITH HEART: Kindnessfirst, inclusive approach to collaboration and vigorous debate that advances business objectives | 14. MODEL EXCELLENCE: Shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | The company leads with a kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives. | The company models excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision-making.</s> | Collaborative and high-performance project team environment. | Aim high by embodying our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | Model excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision making. | Lead with heart by everyone leading at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</s> | 4. MODEL EXCELLENCE: Shared Commitment to Demonstrating Integrity, Accountability, Equality and Clarity Across Communications and Decision Making</s> | Courageous goal to make the most complex biologics ever attempted to protect humankind | Bringing creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered</s> | Shared Commitment to Demonstrating Integrity, Accountability, Equality, and Clarity Across Communications and Decision Making</s> | Mission-driven: working towards protecting humankind from the consequences of bacterial diseases | Collaborative: guided by four enduring core values that prioritize collaboration and inclusion | Innovative: bringing creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered | Ambitious: embodying a collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</s> | Mission to protect humankind from bacterial diseases | Collaborative work environment guided by four core values: Rethink Convention, Aim High, Lead With Heart, Model Excellence | Commitment to scientific excellence, innovation, and integrity within the medical and clinical affairs team.</s> | Vaxcyte values creativity and intellectual diversity to innovate and re-innovate the way vaccines are delivered. | They aim high and embody their collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | They lead with heart, everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances their business objectives. | They model excellence by demonstrating integrity, accountability, equality, and clarity across communications and decision making.</s> | Rethink convention: bring creative and intellectual diversity to every facet of the work done in order to innovate and re-innovate the way vaccines are delivered | Caring: Vaxcyte is committed to protecting humankind from the consequences of bacterial diseases | Courage: Vaxcyte embodies a collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind | Excellence: Vaxcyte strives for world-class finance organization that is customer service-oriented and highly accountable | Passion: Vaxcyte's cultural attributes include caring, courage, excellence, and passion</s> | Kindness-first and inclusive approach to collaboration and vigorous debate that advances 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.</s> | Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives</s> | 1. RETHINK CONVENTION: Creative and Intellectual Diversity to Innovate and ReInnovate the Way Vaccines are Delivered | 2. AIM HIGH: Embodiment of Collectively Audacious Goal to Courageously Make the Most Complex Biologics Ever Attempted to Protect Humankind | 4. MODEL EXCELLENCE: Shared Commitment to Demonstrating Integrity, Accountability, Equality, and Clarity Across Communications and Decision Making</s> | Collaborative culture | Continuous improvement mindset | Kindness-first, inclusive approach to collaboration and vigorous debate that advances business objectives.</s> | 1. RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and reinnovate the way vaccines are delivered. | 2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. | 3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindnessfirst, inclusive approach to collaboration and vigorous debate that advances our business objectives. | 4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</s> | Commitment to protecting humankind from bacterial diseases | Emphasis on continuous improvement and risk mitigation strategies | Rethink Convention: Bring creative and intellectual diversity to every facet of work to innovate and re-innovate the way vaccines are delivered. | Model Excellence: Shared commitment to demonstrating integrity, accountability, equality, and clarity across communications and decision making.</s> | Vaxcyte values creativity and intellectual diversity in every facet of the work they do | They model excellence by demonstrating integrity, accountability, equality and clarity across communications and decision making.</s>
