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Sr. Director, Quality Assurance and Compliance

Employer
Vaxcyte, Inc.
Location
San Carlos, California
Start date
Oct 13, 2024
View more categoriesView less categories
Discipline
Quality, Quality Assurance, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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:

*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.

*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.

*MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
 
Summary:
 
Join Vaxcyte as a Quality Assurance Leader, where you will play a pivotal role in ensuring our continuous inspection readiness and regulatory compliance. This position entails managing and executing a risk-based vendor management program, overseeing the qualification and audit processes for contract service providers, and establishing company processes to identify and manage compliance risks. You will lead and support staff during inspections and audits, maintain strong relationships with internal and external stakeholders, and promote a quality mindset throughout the organization. 
Essential Functions:
    • Manage the implementation, execution, and maintenance of Vaxcyte’s inspection readiness program.
    • Responsible for the execution and maintenance of a risk-based vendor management program.
    • Oversee the qualification and audit process for contract service providers and ensure controls such as quality assurance agreements are in place.
    • Maintain strong relationships with internal and external stakeholders.
    • Establish company processes to identify and manage compliance risks, mitigate and appropriately escalate issues in a timely manner.
    • Monitor current regulatory requirements and assess the potential impact to the organization.
    • Responsible for developing, trending and reporting compliance metrics.
    • Assist in resolution of quality performance issues with vendors.
    • Lead and support staff during various inspection and audit activities, will be the main contact during internal and external audits and inspections.
    • Identify and implement corrective and preventative actions.
    • Establish and revise quality assurance procedures and policies.
    • Lead and support process improvement initiatives.
    • Lead and facilitate Quality Management Reviews.
    • Oversee the quality risk management process and site risk register as applicable.
    • Ensure adherence to Vaxcyte policies and procedures.
    • Ensure continuous inspection readiness and compliance with regulatory requirements.
    • Promote a quality mindset and quality excellence approach to all activities.

Requirements:
    • BS or BA with 12 years relevant industry experience.
    • Demonstrate in-depth knowledge of GMPs, FDA and EU requirements and ICH guidelines.
    • Experience with regulatory authority inspections.
    • Skilled auditor.
    • Knowledge and experience in Risk Management principles.
    • Knowledge in both clinical and commercial product desired.
    • Combination Device Product experience desired.
    • Strong Management and process improvement skills.
    • Demonstrate a high level of independent quality judgment.
    • Demonstrate excellent verbal, written, and interpersonal communication skills.
    • Demonstrate experience leading and contributing through influence and working in cross functional teams
    • Strong sense of ownership in areas of responsibility.

Reports to: VP, Quality Assurance
 
Location: San Carlos, CA
 
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
 
Salary Range: $254,000 – $281,000 (SF Bay Area). Salary ranges for non-California locations may vary.

 
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
 
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.

#LI-JN1

Company

Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate vaccine (PCV) being developed for the prevention of invasive pneumococcal disease. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease.

Company info
Website
Phone
(650) 837-0111
Location
825 Industrial Road, Suite 300
San Carlos
CA
94070
United States

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