V
Sr. Director, Quality Assurance for Quality Control
Vaxcyte
Quality Assurance Engineer
Go
Senior
Full-time
Equity compensation
Flexible working hours
Competitive salary
United States
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Description
- Skills: Go
- Experiences: Senior
- Employments: Full-time
- Benefits: Equity compensation, Flexible working hours, Competitive salary
- Locations: United States (Remote)
Description:
- Lead quality oversight activities related to method validation, release, and in-process testing for Drug Substance and Polysaccharide.
- Provide direct QA support to analytical operations in Switzerland and manage the QA team in San Carlos, ensuring compliance with global regulatory guidelines.
Requirements:
- Bachelor’s degree in Biochemistry, Chemistry, or related field with 15+ years of relevant industry experience.
- Thorough knowledge of FDA, EU, and ICH regulatory guidelines for method qualification and validation in biologics and vaccines.
- Experience in Quality Control with biochemistry, immunoassay, or microbiological assay techniques.
- Excellent organizational, project management, and communication skills.
- Proven ability to build high-performing QA teams and influence stakeholders in a biotech environment.
- Experience in BLA submission and commercial launch is highly desirable.
Benefits:
- Competitive compensation package including comprehensive benefits and equity component.
- Salary range of $229,000 – $268,000 (North Carolina).
- Remote work arrangement with flexibility based on business needs.