Director, Product Quality - Cell Therapy Programs

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Product Quality in the United States.

In this role, you will serve as the strategic and technical leader for product quality across cutting-edge cell therapy programs. You will oversee quality strategy and implementation across the full product lifecycle, ensuring compliance with regulatory standards and alignment with business objectives. This position offers a high-impact opportunity to collaborate with cross-functional teams including manufacturing, regulatory affairs, analytical development, and process sciences. You will provide technical oversight for CMOs, lead risk management initiatives, and drive operational excellence. The ideal candidate combines deep scientific and regulatory knowledge with leadership presence, delivering solutions that balance safety, quality, and business considerations. This role is fully remote, supporting projects across multiple U.S. states.

• Accountabilities
• Lead end-to-end technical quality oversight for drug substance and drug product CMOs.
• Develop and implement comprehensive product quality strategies, including specifications, control strategies, and comparability assessments.
• Support regulatory submissions and serve as Quality lead for responses to regulatory inquiries.
• Advise on commercialization strategies, including in-process controls, stability, and lifecycle management.
• Conduct science- and risk-based evaluation of product and process data to ensure patient-centric, compliant solutions.
• Lead major investigations, change controls, and CAPAs impacting product quality.
• Establish and manage the Product Quality Risk Management framework, including risk registers and mitigation tracking.
• Ensure timely execution of product quality activities such as APQRs, specification justifications, and risk assessments.
• Requirements
• Bachelor’s degree in Biology, Chemistry, Engineering, or related scientific discipline; advanced degree preferred.
• 10+ years of experience in pharmaceutical or biotechnology industry with exposure to MSAT, development, or manufacturing.
• Minimum 5 years in a Quality leadership role supporting late-stage or commercial biologics or cell therapy programs.
• Deep knowledge of cGMP and international regulatory expectations for biologics or cell therapy products.
• Proven experience in technical transfers, process characterization, validation, CPV, and commercialization oversight.
• Strong analytical, decision-making, and problem-solving skills with the ability to interpret complex data.
• Excellent communication skills, including experience with regulatory submissions and cross-functional presentations.
• Demonstrated ability to collaborate effectively across technical and business teams.
• Experience with CDMOs strongly preferred.
• Proficiency in MS Office suite; ability to adapt to rapidly changing environments while maintaining compliance.
• Benefits
• Competitive salary range: $210,000–$226,000.
• Comprehensive health, dental, and vision insurance coverage.
• 401(k) with company match, Flexible Spending Accounts (FSA), and Employee Assistance Program (EAP).
• Generous paid time off (PTO) and holidays.
• Opportunities to work remotely in approved U.S. states.
• Professional development opportunities and exposure to cutting-edge cell therapy innovations.
• Collaborative, inclusive, and mission-driven work environment.
  
  

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.

🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.

📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.

🎯 Based on this analysis, we automatically shortlist the three candidates with the highest match to the role.

🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.