Sr. Manager, Quality Assurance Cqv

**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 the development of dedicated biologics manufacturing facilities. The Sr. Manager, Quality Assurance CQV 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 cGMP regulations as well as expertise in running GMP facilities. Cross-functional teamwork and working with CDMOs is paramount in this role.

**Essential Functions**:

- Collaborates closely with Senior Management, Functional/Department Heads, and project team members.
- Makes sure that accurate and up-to-date records of manufacturing processes, quality control testing, and regulatory compliance activities are available.
- Ensures compliance with regulatory requirements, including GMP, safety and environmental regulations, and other relevant guidelines.
- Supports validation and qualification activities for equipment, processes, and facilities to ensure compliance with regulatory requirements and industry standards.
- Improve productivity and for continuous process improvements
- Ensure preparation, development, review of high-level CQV documentation such as Site Validation Master Plan (SMVP), Project Commissioning / Validation Plans, risk assessments, system/component level Impact Assessments, criticality assessments, Quality Plans, traceability matrices, etc. Ensure adherence to a commissioning and qualification schedule and Validation Project plan for the facility, utilities, process, and analytical equipment.
- Review and approval of commissioning and qualification protocols and reports for facility, utilities, IT-OT, process, and analytical systems and equipment.
- Review and approval of change controls to release facilities, utilities, process, and analytical equipment for GMP manufacturing use.
- Oversee validation activities and deliverables to meet the overall facility and operations milestones.
- Oversee external contractors and vendors during commissioning and qualification activities.
- Prepare, review, and support asset documentation lifecycle (risk assessments, URS, FAT/SAT, IOQ, Commissioning, SOPs, etc.), to support new or existing facilities, utilities, and equipment.
- Ensure tasks and deliverables are executed and accomplished per Project/Validation Master Plan and other required Policies and Procedures.
- Ensure discrepancies are resolved and closed out in a timely manner.
- Ensure preparation of testing templates and qualification protocols using paper and electronic validation systems (e.g. Kneat ).
- Ensure safety is integrated into the design and CQV execution of all projects and activities (reviews with EHS representatives).
- Prepare/review automation sequences, as required for Process Automation / OT systems and eMBR.
- Prepare/review automation sequences, as required for Process Automation / OT systems and eMBR.
- Engage and coordinate CQV activities with other engineering disciplines and other cross-functional departments (process, IT-OT, facilities, procurement, construction management, manufacturing oper