Manager, Quality Assurance, Quality Management Systems

vor 2 Wochen

Visp, Schweiz Vaxcyte Vollzeit

**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.

Vaxcyte is looking for a talented Quality Assurance Manager (QMS), who will be responsible for managing manufacturing documents in a GXP compliant environment. This includes, but is not limited to, batch records, specifications, and memos. The role is focused on maintaining documentation in the Quality Systems associated with the manufacturing and testing of our vaccines and preparing for future clinical trials.

**Essential Functions**:

- Maintenance of the Quality Systems documentation in Veeva (electronic document control system) and other electronic systems where required.
- Perform document specialist functions in QA, including managing the lifecycle of GMP documents in Veeva, including creation, revision, approval, distribution and archival, ensuring compliance with internal procedures and regulatory standards.
- Work closely with quality assurance, external vendors, functional areas and Project Management team for daily management of routing, revisions, approval, and filing of documents within defined timelines.
- Organize and ensure accurate and reliable filing systems for all electronic and paper-based GMP documents.
- Support audits as appropriate (internal and regulatory).

**Requirements**:

- Bachelor’s BA/BS degree or equivalent experience.
- 8+ years of biopharmaceutical industry experience.
- Experience with managing key Quality Management System processes (e.g., Document Control, Change Management, Training).
- 8+ years of experience with document management utilizing EDMS systems, Experience with Veeva QualityDocs preferred.
- Familiarity with documents and records associated with GxP manufacturing and testing activities.
- Understanding of current regulatory expectations including 21CFR Part 11 requirements
- Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results.
- Strong professional interpersonal and communications skills, both verbal and written, to provide clear direction for the business, vendors, and internal stakeholders.
- Strong attention to detail, organizational skills, ability to work in a faced paced environment.
- Ability to meet deadlines and multi-task efficiently.
- Working knowledge with SmartSheet, Microsoft Office Suite, Word, Excel, PowerPoint, Visio, and Adobe.

**Reports to**: Senior Director, Quality Assurance

**Location**: Visp, Switzerland

**Compensation**:
The compensation package will be competitive and includes an equity component.

Vaxcyte Switz

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