Senior Manager, QA (Biotech)

Location: Hybrid role based in San Diego, California, United States. National travel is required for GxP audit readiness, and some cleanroom access is required.

Salary: $160,000–$186,000 annually for candidates working in San Diego.

Company

hirify.global develops products for patients in need within the biotechnology and cell therapy field.

What you will do

• Lead the execution, maintenance, and continuous improvement of GxP quality systems supporting clinical and manufacturing operations.
• Manage document control, training systems, supplier quality, deviations, CAPA, change control, nonconformance, and batch disposition.
• Establish quality metrics, analyze trends, identify risks, and communicate system performance to senior management.
• Lead inspection readiness and oversee internal, external, and regulatory audits through resolution of findings.
• Partner with Clinical Operations, Manufacturing, Regulatory Affairs, and R&D on quality, compliance, and risk decisions.
• Manage, mentor, and develop junior quality staff while driving accountability and continuous improvement.

Requirements

• Bachelor’s degree in life sciences, health sciences, or a related field; an advanced degree is preferred.
• At least 8 years of experience in the cGMP pharmaceutical or biotechnology industry.
• At least 5 years of experience conducting internal and external audits.
• At least 5 years of direct people management or supervisory experience.
• Advanced knowledge of GMP, GCP, GLP, and regulatory frameworks including FDA, EMA, and ICH.
• Valid U.S. work authorization without current or future employer sponsorship is required; visa sponsorship is not available.

Nice to have

• Late-stage clinical to commercial manufacturing experience or stem cell manufacturing experience.
• Experience with electronic QMS or electronic batch record systems.
• Certified Quality Auditor certification or equivalent.

Culture & Benefits

• Collaborative, learning-focused work environment.
• Competitive total compensation package.
• Paid time off in addition to company-observed holidays.
• Medical and dental insurance benefits.
• Onsite gym and other wellness perks.