Senior Manager, Validation, IT, Quality and Compliance

March 19

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $159.3k - $194.7k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Vaxcyte

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Vaxcyte is a biotechnology company focused on developing innovative vaccines to combat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Utilizing advanced chemistry and synthetic techniques, Vaxcyte aims to improve upon existing vaccines with products like their VAX-24 and VAX-31 pneumococcal conjugate vaccines, which target a broad range of bacterial strains. Vaxcyte's approach includes re-engineering the vaccine-making process through the XpressCF™ cell-free protein synthesis platform, aiming to create vaccines that effectively counter bacteria's complex defense mechanisms while maintaining immunogenicity. Their pipeline includes several high-fidelity, broad-spectrum vaccine candidates designed to address significant public health challenges and prevent bacterial infections worldwide.

51 - 200 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• 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. • 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. • 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.

🎯 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.

🏖️ Benefits

The compensation package will be competitive and includes comprehensive benefits and an equity component.