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.

Responsibilities

• Lead and manage critical QA GMP functions overseeing CSPs for Drug Substance and Drug Product activities
• Conduct and oversee validation efforts including protocols and testing for various systems
• Support contract manufacturing, testing, and distribution by managing deviations and quality events
• Collaborate with Technical Operations to ensure compliance of CSP documentation
• Review and approve GxP related documents and ensure regulatory compliance
• Track project progress towards goals and report discrepancies as needed

Requirements

• Bachelor's degree in life science or related field; Master's preferred
• 10 years of QA experience in an FDA regulated industry, preferably in biotech or pharmaceuticals
• Strong knowledge of cGMPs and international regulations
• Excellent communication and organizational skills
• Proven ability to manage complex project plans and timelines

Benefits

• Premium health benefits for employees and dependents
• Financial wellness programs and retirement plans with employer match
• Generous paid time off and a commitment to work-life balance
• Life insurance and disability coverage
• Wellness and employee support programs

Pay

$189,000 – $246,000 annually

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