• Collaborate with Business Development Executives to support new business and cross-sell opportunities across EMEA, primarily focusing on French-speaking opportunities. • Lead discovery conversations to understand customer needs, business processes, and regulatory pain points. • Deliver impactful product demonstrations and presentations that translate technical capabilities into clear customer value. • Help shape solution recommendations that align with customer priorities and support commercial success. • Stay current on developments in chemical regulatory compliance, product stewardship, and related market trends.

• Establish relationships with DePuy Synthes sales, sales agents, commercial operations, supply chain, distribution and franchise customers to solve problems and meet changing operations and regulatory environments. • Define, implement, and validate quality system requirements and systems to meet departmental and business strategies. • Mentor and coach functional partners in the areas of GxP requirements. • Implement and improve systems/processes with focus on; customer and commercial quality, Inspection readiness, quality planning, nonconformance and corrective/preventive action plan development, implementation and effectiveness monitoring. • Provide quality support for existing and new distribution models & processes in the US. • Guide the Operations on the development of standard operating procedures. • Serve as single point of contact for assigned business partners. • Participate in, host and lead audits, inspections, investigations, and remediation activities.

Title: Associate Director, Regulatory CMC Location: San Carlos United States 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, 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: A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. Essential Functions: - Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies - Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance - Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements - Provides CMC regulatory guidance to cross-functional teams and key stakeholders - Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development - Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects - Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters - Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development - Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise Requirements: Bachelor's Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered. - Prior experience preparing/authoring CMC DS sections: - BLA highly preferred. - Post-approval supplements/variations highly preferred. - INDs/IMPDs. - Prior development or manufacturing experience is a plus. - Computer software skills (LIMS, SAP, TrackWise, Veeva will be used). - Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency. - Excellent interpersonal skills to communicate difficult concepts. - Strategic thinking and strong problem-solving skills - Collaborates and communicates in an open, clear, complete, timely, and consistent manner - Strong sense of planning and prioritization, and the ability to work with all levels of management - Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA/Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary. 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.

Role Description The Senior SOX Analyst is responsible for maintaining an effective and sustainable SOX compliance program as the organization continues to grow! - Ensure consistency in control design, documentation standards, and execution across all regions by establishing clear expectations, reviewing control language for precision, and promoting alignment in how controls are evidenced and maintained. - Oversee AuditBoard governance, including timely control updates, certifications, proper archiving of prior-year controls, user access oversight, and identification of system enhancements to improve efficiency and reporting accuracy. - Drive the Annual Design Assessment (ADA) process by coordinating timelines, reviewing submissions for quality and completeness, challenging control design where necessary, and ensuring updates are appropriately reflected in the system. - Evaluate the SOX impact of system implementations, organizational changes, process redesigns, acquisitions, and other business transformations to determine scoping implications, new control requirements, or modifications to existing controls. - Ensure deficiencies are properly evaluated, supported with sufficient evidence, and aggregated in accordance with SOX methodology, including root cause analysis, severity assessment, and alignment with management’s conclusion. - Support walkthroughs and PBC coordination by preparing documentation, aligning control owners on expectations, facilitating auditor discussions, and proactively addressing follow-up inquiries to minimize rework. - Strengthen IPE governance and key report testing by ensuring completeness and accuracy procedures are clearly documented, reports are appropriately validated, and testing standards are applied consistently across manual and automated controls. - Identify and deliver SOX training requirements by assessing knowledge gaps (particularly for new control owners), developing targeted training materials, and providing ongoing education to reinforce accountability, documentation standards, and control awareness. Qualifications - Three or more years’ experience with SOX 404 compliance and internal controls evaluation that followed a controls framework, including all phases of evaluation, documentation, testing, and remediation. - The ideal person will have either public accounting or a combination of public & industry (public company) internal audit experience. - Prior experience with US owned groups. - Strong background in financial accounting and audit. - Advanced Excel skills. - Strong analytical and problem-solving skills with attention to detail. - Able to work to tight deadlines, within a small team. - Proficient process facilitation, project management, and analytical skills. - Experience navigating and leading in environments of transformation/change. Benefits - Competitive compensation. - Generous benefits package, including full health insurance (medical, dental, and vision). - 401(k) plan. - Life insurance. - Disability coverage. - Opportunity to participate in a company incentive plan. Company Description GXO is a leading provider of cutting-edge supply chain solutions to the most successful companies in the world. We help our customers manage their goods most efficiently using our technology and services. Our greatest strength is our global team – energetic, innovative people of all experience levels and talents who make GXO a great place to work. We are proud to be an Equal Opportunity employer including Disabled/Veterans. GXO adheres to CDC, OSHA, and state and local requirements regarding COVID safety. All employees and visitors are expected to comply with GXO policies which are in place to safeguard our employees and customers. All applicants who receive a conditional offer of employment may be required to take and pass a pre-employment drug test.