Senior Manager, Quality Assurance

The company seeks a Senior Manager of Quality Assurance to oversee QA for Drug Substance intermediates and raw materials, ensuring regulatory compliance and leading cross-functional initiatives.

This position acts as the dedicated Quality Assurance lead for all Drug Substance intermediate and custom raw material activities. The role is responsible for guaranteeing that operations carried out by Contract Manufacturing Organizations align with the company’s quality benchmarks and global regulatory expectations. Additionally, the individual will serve as the main QA liaison within various internal and external collaborative groups.

Responsibilities

• Act as the primary QA representative for Drug Substance intermediates and custom raw materials during manufacturing.
• Represent the QA department in both internal and external cross-functional meetings.
• Evaluate and authorize internal and external records to ensure compliance, including handling deviations, risk assessments, change controls, and CAPAs.
• Perform detailed QA assessments of batch records executed by CMOs in line with current regulatory guidance and industry standards, and follow up on CMO responses.
• Review and submit disposition packages for Drug Substance intermediates and custom raw materials to management for release, adhering to global regulatory requirements.
• Create, implement, and update procedures and policies for Drug Substance intermediate and custom raw material manufacturing within the quality organization as needed.
• Lead the resolution of quality performance issues with contract manufacturers and proactively escalate matters to management.
• Offer guidance on supplier manufacturing investigations.
• Assist with technology transfer activities and review related documentation.
• Engage in process improvement initiatives.
• Collaborate with key stakeholders to develop solutions for complex issues while upholding high quality standards.

Requirements

• Hold a BS or BA degree alongside at least eight years of Quality Assurance experience.
• Possess extensive knowledge of GMPs, FDA/EMA regulations, and ICH guidelines.
• Demonstrate strong attention to detail.
• Have knowledge of both clinical and commercial product environments (desired).
• Exhibit excellent verbal, written, and interpersonal communication skills.
• Show experience leading and contributing through influence in cross-functional teams.
• Be able to thrive in a fast-paced team setting, consistently meeting aggressive timelines while prioritizing tasks for multiple projects.
• Demonstrate the ability to adapt to changing priorities.
• Have strong overall knowledge of biologics manufacturing processes and Quality Systems.
• Possess required experience with good documentation practices, technical writing, and cGMP standards.

What the company offers

• The compensation package is competitive and includes comprehensive benefits and an equity component.

About the company

Vaxcyte is a clinical-stage vaccine innovation company focused on engineering high-fidelity vaccines to protect humanity from bacterial diseases. The company's work is guided by four core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE.

• RETHINK CONVENTION
• AIM HIGH
• LEAD WITH HEART
• MODEL EXCELLENCE