Senior Manager, Quality Assurance, Drug Product

Senior Manager, Quality Assurance, Drug Product

Vaxcyte is a clinical‑stage vaccine innovation company engineering high‑fidelity vaccines to protect humankind from the consequences of bacterial diseases. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.

• RETHINK CONVENTION:
  Bring creative and intellectual diversity to innovate vaccine delivery.
• AIM HIGH:
  Embody audacious goal to make complex biologics to protect humankind.
• LEAD WITH HEART:
  Kindness‑first, inclusive collaboration and vigorous debate advance business objectives.
• MODEL EXCELLENCE:
  Demonstrate integrity, accountability, equality and clarity across communications and decision making.

The Senior Manager, Quality Assurance, Drug Product will play a critical role in ensuring the quality, safety, and compliance of commercial vaccine products. This leader will oversee QA activities related to manufacturing, batch disposition, deviations, and risk management, while actively participating in audits and continuous improvement initiatives.

• Provide QA oversight of Contract Manufacturing Organizations.
• Represent QA at internal cross‑functional team meetings and Joint Project Team meetings.
• Lead batch disposition activities such as review of executed batch records, environmental monitoring, and quality control data.
• Review and approve documentation such as master batch records, deviations, risk assessments, change controls, and CAPAs.
• Lead deviation and product complaint investigations.
• Drive resolution of quality performance issues with the contract manufacturer.
• Support validation activities.
• Identify opportunities to streamline QA processes and systems.
• Champion initiatives to enhance quality culture and operational excellence across the organization.
• Interact with key stakeholders to develop solutions to complex issues.
• Participate in compliance audits as required (health authority and contract manufacturer).
• Promote a quality mindset and quality excellence approach to all activities.
• Mentor and coach QA staff to strengthen technical capabilities and regulatory compliance mindset.

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, or a related field.
• Minimum of 8 years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry.
• Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards.
• Knowledge and experience in Risk Management principles.
• Experience in both clinical and commercial parenteral drug product required.
• Strong Management and process improvement skills.
• Demonstrated experience managing batch record review, deviations, and change management.
• Demonstrate experience in annual product reports.
• Great organization skills and attention to detail.
• In‑depth understanding of aseptic manufacturing (biologics) operations.
• Ability to prioritize multiple assignments and changing priorities.
• Excellent problem‑solving skills and the ability to manage complex investigations and root cause analyses.
• Strong written and verbal communication skills, with the ability to clearly present quality issues to cross‑functional teams.

Director, Quality Assurance, Drug Product

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

$166,000 – $193,000 (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.