Senior Manager, Quality Assurance

About the role

The Senior Manager, Quality Assurance leads QA activities for drug substance intermediates and custom raw material manufacturing at contract manufacturing organizations. This position ensures compliance with Vaxcyte’s quality standards and global regulatory requirements while supporting continuous improvement.

Key responsibilities

• Act as the QA representative for drug substance intermediates and custom raw materials, reviewing batch records, disposition packages and technology transfer documents.
• Review and approve deviations, risk assessments, change controls and CAPAs, and drive resolution of quality issues with CMOs.
• Develop, implement and maintain QA procedures and policies for the relevant manufacturing activities.
• Support technology transfer activities and participate in process improvement projects.

Required profile

• BS or BA with a minimum of 8 years of Quality Assurance experience, preferably in biologics manufacturing.
• In‑depth knowledge of GMP, FDA/EMA regulations and ICH guidelines.
• Strong attention to detail and ability to work in a fast‑paced, matrixed environment.
• Excellent verbal, written and interpersonal communication skills.

Required skills

• GMP
• FDA regulations
• EMA regulations
• ICH guidelines
• cGMP documentation practices