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Associate Director of Process Validation and Risk Management

VaxcyteSan Carlos, California, United States
On-site Full-time $174K/yr - $203K/yr

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Experience Level

Senior Level Manager

Qualifications

Key Responsibilities:Lead the strategic direction and execution of process validation initiatives. Facilitate risk management assessments and develop frameworks to mitigate potential issues. Collaborate effectively with cross-functional teams to align on validation strategies. Ensure compliance with regulatory requirements and internal standards. Communicate validation strategies and results to stakeholders and regulatory authorities.

About the job

Join Our Mission to Protect Humanity!

Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines that aim to safeguard humanity from the severe health implications of bacterial diseases. We are committed to eradicating or effectively treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella, with a clear and defined path toward success.
 
Our Approach: What we do is just as vital as how we do it! Our collaborative efforts are anchored by four core values:
 
*RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work to innovate and re-innovate vaccine delivery.
 
*AIM HIGH: We embody our ambitious goal to courageously tackle the most complex biologics designed to protect mankind.
 
*LEAD WITH HEART: At Vaxcyte, everyone leads with kindness and inclusiveness, fostering collaboration and spirited debate that drives our business objectives forward.
 
*MODEL EXCELLENCE: The magnitude of our challenge necessitates our collective commitment to integrity, accountability, equality, and clarity in communications and decision-making.

Position Overview:

The Associate Director of Process Validation and Risk Management will spearhead and facilitate commercial process validation and risk management activities throughout Vaxcyte's comprehensive manufacturing processes. This role is pivotal in shaping technical strategies, executing plans, and coordinating across functions to ensure commercial readiness, regulatory compliance, and effective lifecycle management.

The successful candidate will provide leadership to ensure our organization is adept at designing, executing, and communicating process validation and risk management strategies to internal stakeholders, external partners, and regulatory bodies.

This position reports to the Senior Director of Process Validation within the Global MSAT organization and collaborates on the overarching validation strategy, with primary accountability for process validation execution and risk management frameworks supporting commercial manufacturing.

 

About Vaxcyte

Vaxcyte is at the forefront of clinical-stage vaccine innovation, committed to creating high-fidelity vaccines that will help protect humanity from serious bacterial diseases. Our work is driven by a clear mission and a defined path toward success, focused on addressing severe health risks posed by bacterial infections.

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