Sr. Director, Quality Assurance for Quality Control

Accountabilities

• Provide strategic and operational quality leadership across analytical operations, ensuring regulatory compliance, effective quality systems, and successful collaboration with internal teams and external partners.
• Lead QA oversight for Quality Control activities related to analytical methods, validation, qualification, release testing, and in-process testing for drug substances and vaccine components.
• Serve as a key quality partner for internal stakeholders and external organizations, including contract manufacturing organizations and testing laboratories.
• Review and approve GMP documentation, including specifications, certificates of analysis, validation reports, deviations, change controls, risk assessments, CAPAs, and analytical data packages.
• Provide quality guidance on reference standards, analytical methods, protocols, and laboratory processes to ensure compliance with applicable regulations.
• Partner with Quality Control, vendor management, and external laboratories to establish performance metrics and improve operational effectiveness.
• Drive resolution of quality issues, including investigations related to testing deviations, out-of-specification results, and compliance risks.
• Review quality agreements and support regulatory documentation activities, including submissions and responses to health authority inquiries.
• Participate in audit preparation and maintain ongoing inspection readiness across analytical programs.
• Develop and improve GMP policies, procedures, and quality practices to strengthen organizational compliance.
• Build and promote a culture of quality excellence, accountability, and continuous improvement across internal teams and external partners.
• Lead and develop geographically distributed QA teams while ensuring consistent quality standards across locations.

Requirements

• The ideal candidate is an accomplished quality assurance leader with extensive experience in biotechnology, vaccines, or biologics, combining regulatory expertise with strong leadership and collaboration skills.
• Bachelor’s degree in Biochemistry, Chemistry, Life Sciences, or a related field with 15+ years of relevant industry experience.
• Deep knowledge of FDA, EU, and ICH regulations, as well as pharmacopeial requirements related to analytical method qualification and validation.
• Proven experience applying regulatory requirements to develop practical analytical quality strategies.
• Strong background working with biochemical, immunoassay, or microbiological testing methods within a Quality Control environment.
• Experience leading analytical validation, method transfer, and qualification activities.
• Demonstrated ability to build and develop high-performing QA teams in fast-paced biotechnology environments.
• Experience managing global teams across multiple sites or countries and establishing consistent GMP standards.
• Strong project management skills with the ability to manage multiple priorities and complex timelines.
• Excellent written and verbal communication skills with the ability to influence executives and cross-functional stakeholders.
• Experience with quality risk management principles and continuous improvement initiatives.
• Ability to interpret complex scientific and operational information across drug and vaccine development programs.
• Experience working with contract manufacturing organizations and external testing partners globally.
• Previous experience supporting BLA submissions and commercial product launches is highly desirable.

Benefits

• Competitive compensation package with a salary range of $229,000 - $268,000 depending on location and experience.
• Comprehensive benefits package designed to support employee health and well-being.
• Equity component as part of the total compensation package.
• Fully remote work arrangement with flexibility based on business needs.
• Opportunity to contribute to innovative healthcare solutions with global impact.
• Leadership role with significant influence over quality strategy and operational excellence.
• Collaboration with multidisciplinary scientific, technical, and business teams.
• Opportunity to shape quality culture and build scalable systems within a growing organization.