Sr. Director, Quality Assurance for Quality Control in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Director, Quality Assurance for Quality Control based in United States.

This senior leadership role is responsible for driving quality excellence across complex analytical and manufacturing programs within a fast-paced biotechnology environment.
The position provides strategic QA oversight for Quality Control activities supporting vaccine development, ensuring compliance with global regulatory standards and maintaining product quality.
You will partner with cross-functional teams including Quality Control, Process Development, Regulatory, Manufacturing, and external collaborators to support critical programs.
The role combines technical expertise, operational leadership, and global collaboration to strengthen analytical strategies and GMP compliance.
You will influence quality systems, guide investigations, support regulatory submissions, and help establish a culture of continuous improvement.
This opportunity is ideal for an experienced quality leader passionate about advancing innovative healthcare solutions and building high-performing teams.

The Sr. Director, Quality Assurance for Quality Control will 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.

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.

• 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.