Vaxcyte, Inc
Senior Manager, Quality Assurance, Raw Materials
Vaxcyte, Inc, San Carlos, California, United States, 94071
Senior Manager, Quality Assurance, Raw Materials
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, 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: The Sr. Manager, QA, Raw Materials ensures quality oversight and compliance across manufacturing activities. This role serves as the QA liaison for internal teams and external partners, reviewing and approving key documentation and materials, driving resolution of quality issues, and ensuring adherence to regulatory standards. The position also supports process improvements, policy development, and effective collaboration to uphold Vaxcyte’s commitment to quality excellence.
Essential Functions:
Serve as QA Manufacturing representative for Critical Raw Materials.
Represent Quality Assurance at internal and external cross functional team meetings, providing quality input and oversight.
Review and approve internal and external documentation for compliance including Master Batch Records, deviations, risk assessments, change controls, and CAPAs.
Perform QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses as needed.
Prepare disposition package of Critical Raw Materials to enable timely release.
Review and approve Raw Materials shipment authorization forms in accordance with established procedures.
Develop, implement, and maintain procedures and policies related to critical Raw Materials and the Vaxcyte quality organization, ensuring alignment with quality and regulatory standards.
Identify compliance gaps and drive resolution of quality and performance issues with contract manufacturers and proactively escalate issues to management, when appropriate.
Provide guidance on Manufacturing investigations and ensure implementation of effective Corrective and Preventative Actions.
Exercise sound judgement and decision-making.
Facilitate process improvement projects to enhance efficiency, compliance, and quality performance.
Collaborate with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.
Requirements:
BS or BA with a minimum 8 years of experience. Other combinations of education and/or experience may be considered.
In-depth knowledge of GMPs, FDA regulations and ICH guidelines.
Strong attention to detail.
Knowledge in both clinical and commercial product.
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.
Strong overall knowledge of manufacturing processes and Quality Systems.
Reports to:
Director, Quality Assurance Raw Materials
Location:
San Carlos, CA; Open to remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range:
$164,000 - $191,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.
Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.
As set forth in Vaxcyte’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Select...
Voluntary Self-Identification of Disability Form CC-305
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OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.
How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:
Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury
Disability Status Select...
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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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: The Sr. Manager, QA, Raw Materials ensures quality oversight and compliance across manufacturing activities. This role serves as the QA liaison for internal teams and external partners, reviewing and approving key documentation and materials, driving resolution of quality issues, and ensuring adherence to regulatory standards. The position also supports process improvements, policy development, and effective collaboration to uphold Vaxcyte’s commitment to quality excellence.
Essential Functions:
Serve as QA Manufacturing representative for Critical Raw Materials.
Represent Quality Assurance at internal and external cross functional team meetings, providing quality input and oversight.
Review and approve internal and external documentation for compliance including Master Batch Records, deviations, risk assessments, change controls, and CAPAs.
Perform QA review of CMO executed batch records in compliance with current regulatory guidance and industry practices and follow up on CMO responses as needed.
Prepare disposition package of Critical Raw Materials to enable timely release.
Review and approve Raw Materials shipment authorization forms in accordance with established procedures.
Develop, implement, and maintain procedures and policies related to critical Raw Materials and the Vaxcyte quality organization, ensuring alignment with quality and regulatory standards.
Identify compliance gaps and drive resolution of quality and performance issues with contract manufacturers and proactively escalate issues to management, when appropriate.
Provide guidance on Manufacturing investigations and ensure implementation of effective Corrective and Preventative Actions.
Exercise sound judgement and decision-making.
Facilitate process improvement projects to enhance efficiency, compliance, and quality performance.
Collaborate with key stakeholders to develop solutions to complex issues while promoting quality standards of excellence.
Requirements:
BS or BA with a minimum 8 years of experience. Other combinations of education and/or experience may be considered.
In-depth knowledge of GMPs, FDA regulations and ICH guidelines.
Strong attention to detail.
Knowledge in both clinical and commercial product.
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.
Strong overall knowledge of manufacturing processes and Quality Systems.
Reports to:
Director, Quality Assurance Raw Materials
Location:
San Carlos, CA; Open to remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range:
$164,000 - $191,000 (SF Bay Area). Salary ranges for non-California locations may vary.
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.
Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.
As set forth in Vaxcyte’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:
A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Select...
Voluntary Self-Identification of Disability Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.
Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.
How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:
Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury
Disability Status Select...
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr