Associate Director, Quality Assurance - Technical

This role will lead technical initiatives focused on scalable systems, platform reliability, and meaningful business transformation. You will work across engineering, product, operations, and business stakeholders to translate complex requirements into practical technology solutions. The position offers the opportunity to influence architecture, execution quality, and the technology capabilities that enable long-term growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Lead and support analytical qualification, validation, and transfer of analytical methods for both small and large molecules
• Review and oversee analytical validation activities including Method Validation Protocols and Raw Data Review
• Serve as primary contact for analytical questions and resolution with cross functional groups and vendors
• Provide subject matter expertise in risk assessment activities impacting product quality
• Support product stability programs by reviewing and approving related protocols and reports
• Assist in the analytical review of data for regulatory submissions
• Contribute to the development of internal policies and ensure compliance with regulatory requirements

Qualifications

• Bachelor's degree in life science or related field required, preferably Chemistry, Biology, or Chemical Engineering
• 8+ years of experience in an analytical function supporting drug/biologics development in the biotechnology or pharmaceutical industry
• Direct GMP Quality Assurance experience with Analytical Qualification/Validation and/or Quality Systems
• Broad knowledge of cGMPs (CFR/ICH) and international regulations

Pay

$150,000 – $195,000 annually

Benefits

• Premium health offerings and financial benefits for employees and dependents
• Wellness and employee support programs including life insurance and disability coverage
• Retirement plans with employer matching contributions
• Generous paid time off to support work-life balance