Remote Sr. Director, Quality Assurance for Quality Control

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.