Senior Director, Validation and Quality Engineering (Biotech)

TL;DR

Senior Director, Validation and Quality Engineering (Biotech): Develop and lead validation function supporting process, analytical, facility, equipment, and computer system validation with an accent on CQV, cleaning, aseptic process, process, and shipping validation. Focus on establishing quality engineering function, quality data science roadmap, and continuous improvement tools for GxP compliance in cell therapy manufacturing.

Location: Hybrid in South San Francisco or Newark, CA (3 days/week onsite required). Candidates must be authorized to work in the U.S.

Salary: $230,000–$270,000 per year

Company

Clinical-stage biotechnology company pioneering allogeneic CAR T cell (AlloCAR T) therapies for cancer and autoimmune disease.

What you will do

• Develop and oversee validation strategies, master plans for products, facilities, and computer systems aligned with regulations.
• Direct CQV of facilities/equipment, cleaning, aseptic process, process, and shipping validation activities.
• Lead validation and quality engineering team, manage contractors/vendors for timely delivery.
• Establish GxP-compliant validation program via procedures/policies and quality data science roadmap.
• Partner cross-functionally on validation/QE deliverables, risk management, and regulatory support.
• Champion data analytics, operational excellence, statistical expertise for process improvement and inspections.

Requirements

• Bachelor’s in engineering, chemistry, or biological sciences (PhD preferred); 10+ years in technical QA/manufacturing/engineering, 5+ years management.
• Cell/gene therapy experience plus; ASQ Auditor/Quality Engineer certifications preferred.
• Comprehensive GxP knowledge, pharma/biologics industry experience, risk management in GMP.
• Proficient in technical documents, MS Office, statistical software (Data Lake, R Shiny, Tableau).
• Authorized to work in the U.S.; excellent communication for senior audiences.
• Comfortable in fast-paced biotech with minimal direction.

Culture & Benefits

• Collaborative, dynamic biotech environment with talented team.
• Competitive compensation including annual bonus, equity.
• Health insurance, generous time off, 2 annual company-wide holiday shutdowns.

Hiring process

• Standard biotech hiring with focus on experience in cell therapy and GxP validation.