Lab Compliance Manager

Vaxcyte, Inc; San Carlos (CA); Hybrid; USD 153,000 - 178,000; Full time

Benefits offered by this job

Equity component

Competitive benefits

Job summary

Vaxcyte, Inc is seeking a hands-on Lab Compliance Manager to join the Global Analytical organization in San Carlos, CA. You will partner with QA to implement quality policies in the AD labs and guide the transition to GMP-compliant operations for Phase I/II programs.

You will directly manage the Sample Management Specialist, maintain ALCOA+ data integrity, and ensure controlled documentation, equipment qualification, and inspection readiness across the laboratory setting.

Qualifications

• Bachelor's degree in life sciences or equivalent with relevant work experience.
• 8+ years in compliance, quality, analytical or lab roles in biopharma/vaccine.
• GMP/GLP knowledge and practical lab application.

Responsibilities

• Directly manage the Sample Management Specialist and ensure GDP standards are met.
• Translate QA policies into AD lab SOPs, work instructions and forms.
• Support QA-driven quality processes (change control, investigations, CAPA) in Phase I/II programs.
• Ensure ALCOA+ data integrity and GDP-compliant records.
• Oversee equipment qualification (IQ/OQ/PQ) and calibration schedules.
• Maintain inspection-ready documentation and support internal audits/inspections.

Skills

GMP/GLP knowledge

Documentation practices

Lab compliance

QA collaboration

People management

Training

Education

Bachelor's degree in life sciences

Tools

Benchling

LIMS

Job description

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.

WHATwe do is every bit as important asHOWwe 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:

Vaxcyte is seeking a hands-on and detail-oriented Lab Compliance Manager to join our Global Analytical organization in San Carlos, CA. The Analytical Development (AD) laboratories within Global Analytical support Vaxcyte's CMC programs by performing method development, supporting method transfer, and executing various characterization testing activities that enable regulatory filings. This role will serve as the primary compliance partner for the AD laboratories, working collaboratively with Quality Assurance (QA), to operationalize established quality policies and procedures within the lab setting.

Additionally, along with ensure the AD labs are aligned with Vaxcyte Quality requirements, the individual will be key in supporting an ongoing effort to evaluate and enhance the AD laboratories to enable operation as a Phase I/II early clinical release and stability testing QC laboratory. This requires an individual with a solid understanding of laboratory GMP requirements who can help guide lab personnel through the transition from a non-GMP to a GMP-compliant operating environment. The Lab Compliance Manager will directly manage the Sample Management Specialist and will report to the Director of Infrastructure and Capabilities in Global Analytical.

Essential Functions:

• Directly manage the Sample Management Specialist, providing day-to-day oversight of sample receipt, logging, storage, distribution and disposition activities to ensure compliance with approved SOPs, chain-of-custody requirements and GDP standards.
• Support the Sample Management process by stepping in and managing samples during times of high sample volume.
• Partner with QA to translate established quality policies and procedures into AD laboratory-specific SOPs, work instructions and forms; serve as the primary author of lab-level controlled documents with QA review and approval.
• Support implementation of laboratory quality processes - including change control, deviation management, OOS/OOT investigations and CAPA - in alignment with QA-approved frameworks and applicable regulatory expectations for Phase I/II programs.
• Implement QA-defined data integrity requirements within the AD laboratory, ensuring all staff adhere to ALCOA+ principles across paper-based and electronic records, including systems such as Benchling and instrument data acquisition software.
• Maintain method qualification records and lifecycle tracking documentation, including qualification status, method changes and requalification needs, ensuring records are complete and inspection-ready.
• Ensure equipment qualification activities (IQ, OQ, PQ) for AD laboratory instruments are in accordance with QA-approved protocols and maintain calibration and preventive maintenance schedules to ensure equipment remains in a qualified state. Additionally partner with Facilities & Engineering to oversee the AD equipment as a whole.
• Ensure equipment logbooks and qualification records are maintained in a manner consistent with GDP requirements and inspection readiness expectations.
• Partner with the Analytical Science and Technology (ASAT) group to ensure robust oversight is in place for the receipt, qualification, storage, traceability and controlled disposal of reference standards and critical reagents used in AD laboratory testing.
• Coordinate and deliver role-based laboratory training in alignment with QA-established training requirements, maintaining training records and qualification documentation for all AD laboratory personnel.
• Ensure AD laboratory documentation, records and daily practices are maintained in a state of inspection readiness; support QA during internal audits and regulatory inspections by serving as the lab-level point of contact for compliance-related questions.

Requirements:

• Bachelor's degree in a life sciences discipline (Chemistry, Biochemistry, Biology or related field), or equivalent combination of education and relevant work experience.
• 8+ years of experience in a compliance, quality, analytical or laboratory role within the biopharmaceutical, vaccine or related life sciences industry.
• Working knowledge of GMP and/or GLP principles and their practical application in a laboratory setting, including familiarity with the distinction between GMP policy and lab-level operational procedures.
• Experience authoring or contributing to controlled documents such as SOPs, work instructions, qualification protocols or investigation reports in a regulated environment.
• Familiarity with data integrity principles (ALCOA+) and Good Documentation Practices (GDP), with demonstrated ability to apply these in day-to-day laboratory operations.
• Experience executing or supporting equipment qualification activities in a regulated analytical or QC laboratory environment.
• Strong interpersonal and collaboration skills, with the ability to work effectively with QA, Analytical Development scientists and cross-functional teams.
• Effective written and verbal communication skills, with demonstrated ability to translate compliance requirements into clear practical laboratory procedures.
• Prior experience in a people management or mentorship capacity or demonstrated readiness to take on direct management responsibilities.

Preferred:

• Experience at a clinical-stage biopharmaceutical or vaccine company, ideally in a role interfacing with both QA and analytical laboratory functions.
• Familiarity with FDA expectations for Phase I/II QC or analytical laboratory operations supporting early clinical biologics or vaccine programs.
• Experience with electronic laboratory or quality systems such as Benchling, LIMS or comparable platforms.
• Exposure to 21 CFR Part 11 and electronic records/electronic signatures (ERES) compliance in a laboratory context.
• Prior experience supporting internal audits or regulatory inspections.
• Familiarity with ICH guidelines relevant to analytical methods and early clinical development (Q2, Q6, Q8, Q10).

Reports to:

Director, Infrastructure & Capabilities

Work Arrangement (may be adjusted based on business needs, job responsibilities or changes to company policy):

Hybrid (minimum of 3 days per week onsite)

Compensation:

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range:

$153,000 - $178,000 (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.

Recruitment Fraud Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at vaxcyte.com/careers.

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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential 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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis 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.