Manager, Quality Assurance, Polysaccharide

VaxcyteVispHybrid, Onsite

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:

As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is initiating development of dedicated biologics manufacturing facilities. This position will lead all aspects of manufacturing activities related to Process Validation, commercial Launch, and routine GMP Manufacturing to ensure the efficient and compliant production of Vaxcyte's products.Working closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development and Regulatory functions as well as with CDMOs; this position will oversee all hands-on operations of Vaxcyte’s GMP manufacturing locations and support the implementation of the global manufacturing network strategy.

This role will be responsible for timely, compliant, secure, and uninterrupted supply of Vaxcyte’s innovative therapies. It is necessary to possess solid knowledge of GxP (GMP, GLP, GCP) regulations as well as expertise in running GMP facilities. Cross-functional teamwork and working with CDMOs is paramount in this role. This position will report to the Senior Director QA of Vaxcyte, Visp, Switzerland.

Essential Functions:

QA Manufacturing representative for Polysaccharide at Vaxcyte.
Represent QA at internal and external cross functional team meetings.
Review and approve internal and external documentation for compliance such as, deviations, risk assessments, change controls, and CAPAs.
Provide thorough QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses.
Prepare disposition package of Polysaccharides per global applicable regulatory requirements and provide to management for release.
Review and approve Polysaccharide shipment authorization forms.
Develop, implement and maintain procedures and policies as they apply to Polysaccharide manufacturing for the Vaxcyte quality organization as needed.
Drive the establishment of Quality Agreements and other required regulatory documentation according GMP
Drive resolution of quality performance issues with contract manufacturers and proactively escalate issues to management.
Provide guidance on supplier manufacturing investigations.
Support technology transfer activities and review of technology transfer documents.
Participate in process improvement projects.
Interact with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.

Requirements:

BS or BA with at least 5 years Quality Assurance experience.
In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines.
Strong attention to detail.
Knowledge in both clinical and commercial product desired.
Excellent verbal, written, and interpersonal communication skills.
Experience leading and contributing through influence and working in cross functional teams.
Ability to work in a fast-paced team environment, and to consistently meet aggressive timelines while prioritizing tasks for multiple projects.
Ability to adapt to changing priorities.
Strong overall knowledge of biologics manufacturing processes and Quality Systems.
Required experience with good documentation practices, technical writing, and cGMP standards.

Reports to: Senior Director, Quality AssuranceLocation: Visp, Switzerland Compensation:The compensation package will be competitive and includes an equity component.Vaxcyte Switzerland GmbHRottenstrasse 53930 Visp, ValaisSwitzerlandWe 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.#LI-JN1Apply 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>

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