Sr. Director, Quality Assurance for Quality Control

Responsibilities

• Lead quality oversight for method validation, release and in-process testing
• Serve as the primary QA liaison with external collaborators and support analytical needs
• Represent QA at cross-functional team meetings both internally and externally
• Review and approve GMP documentation for compliance and apply technical expertise
• Establish key performance indicators for vendor effectiveness with QC and contract labs
• Resolve quality performance issues with contract manufacturers and testing organizations
• Drive quality investigations relating to testing deviations and out-of-spec results

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, or related field, with 15+ years of relevant experience
• Thorough knowledge of FDA, EU, and ICH regulatory guidelines for biologics and vaccines
• Experience with biochemistry, immunoassay, or microbiological assay techniques in Quality Control
• Strong organizational and project management skills under tight timelines
• Excellent written and verbal communication skills for cross-functional collaboration
• Proven expertise in analytical assay validation and transfer
• Experience leading QA teams and influencing stakeholders in a biotech environment

Benefits

• Comprehensive benefits package for employees
• Equity component included in compensation package
• Remote work arrangement available based on business needs