Senior Manager, Clinical Quality Assurance

Regulatory Jobs; San Carlos (CA); Hybrid; USD 163,000 - 191,000; Full time

Job summary

Vaxcyte, a clinical-stage vaccine company in the SF Bay Area, seeks a Senior Manager, Clinical Quality Assurance to lead global investigations, CAPA, and QA activities ensuring compliance with GCP and FDA guidelines.

The role requires 9+ years in QA within clinical or pharmaceutical settings, strong leadership, and collaboration across global teams, with hybrid onsite/remote work in the San Carlos area.

Qualifications

• Bachelor's degree in a life sciences field.
• Minimum of 9 years in Quality Assurance within clinical/pharma.
• Knowledge of FDA regulations and ICH guidelines.
• Experience with QMS systems (Veeva preferred).
• GCP QA certification preferred.
• Excellent communication and collaboration skills.
• Willing to travel up to 15%.
• Experience across all phases of clinical development.

Responsibilities

• Lead global investigations and support CAPA plans in compliance with applicable regulations/guidelines, SOPs and project specific instructions.
• Manage Quality Issues and serious breach investigations.
• Review, approve Investigations, Root Cause Analysis (RCA), CAPA and Effectiveness Check (EC) plans.
• Track until closure quality events from Quality Issues, Audits, Inspections or during QA activities.
• Manage/oversee quality event updates in the eQMS.
• Plan, schedule, and conduct risk based and For Cause audits of clinical investigators sites, CROs, and other GCP vendors.
• Support regulatory agency inspection readiness activities, including mock inspections, gap assessments, and inspection response coordination.
• Evaluate policies and procedures for compliance and provide recommendations for continuous process improvements.
• Support QA initiatives/projects for quality, process improvements.
• Promote a quality mindset and quality excellence across activities.
• Understands and interprets regulatory policies pertaining to GCP and implements compliant processes.

Skills

Quality Assurance

GCP/GxP

CAPA investigations

Root Cause Analysis

Regulatory inspections

Quality systems

Communication skills

Travel readiness

Education

BS in life sciences

Tools

Veeva

Job description

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.

WHATwe do is every bit as important as HOWwe 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:

We are seeking a dedicated and experienced Senior Manager, Clinical Quality Assurance, to join our dynamic team. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence. This role requires an individual who can work with teams to ensure compliance with regulatory requirements and achieve our mission of delivering high-quality healthcare solutions.

Essential Functions:

• Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.
• Manage Quality Issues and serious breach investigations.
• Review, approve Investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans.
• Track until closure quality events from Quality Issues, Audits, Inspections or during similar QA activities.
• Manage/oversee quality event update in eQMS.
• Plan, schedule, and conduct risk based and For Cause audits of clinical investigators sites, CROs, and other GCP vendors.
• Support regulatory agency inspection readiness activities, including mock inspections, gap assessments, and inspection response coordination.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Support in QA initiatives/projects for quality, process improvements.
• Promotes a quality mindset and quality excellence approach to all activities.
• Understands and interprets regulatory agencies policies and guidance as it pertains to GCP requirements and assists in the implementation of compliant processes at Vaxcyte.

Requirements:

• BA or BS in related field.
• Minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry. Other combinations of education and/or experience may be considered.
• Knowledge of QMS system (Veeva preferred).
• GCP QA Certification preferred (RQAP-GCP, or similar).
• Experience across all phases of clinical development.
• Knowledge of applicable FDA regulations and ICH guidelines.
• Proficiency in QA tools and software (Veeva preferred).
• Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
• Strong analytical and problem-solving skills, with a keen attention to detail.
• Ability to travel up to 15%.

Reports to:Senior Director, Clinical Quality Assurance

Location:San Carlos, CA; Open to Remote

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

Hybrid (minimum of 3 days per week onsite) / Remote

Compensation:

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

Salary Range: $163,000 – $191,000 (SF Bay Area). Salary ranges for non-California locations may vary.

Equal Opportunity

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.