Senior Clinical Quality Operations Manager

Location: Jersey City, NJ or Millbrae, CA; onsite presence required at least 3 days per week

Salary: $157,000–$189,000 per year, depending on skills, competency, and market demand.

Company

hirify.global Therapeutics is a biopharmaceutical company developing novel treatments for life-threatening diseases through a platform combining chemistry, engineering, computation, and biology.

What you will do

• Lead operational quality management and inspection-readiness activities across assigned clinical development programs.
• Embed quality-by-design principles, Critical to Quality assessments, risk-based quality plans, and study-specific procedures into clinical trials.
• Analyze clinical trial data to identify signals, trends, emerging risks, and process improvement opportunities.
• Partner with study teams to document and monitor vendor and CRO performance against quality expectations.
• Support GCP inspection preparation, management, follow-up, regulatory monitoring, and inspection-readiness activities worldwide.
• Lead CAPA implementation, corrective actions, remediation, prevention activities, and related training.

Requirements

• 8+ years of related experience with a Bachelor’s degree, or 6+ years with a postgraduate degree.
• In-depth knowledge of GCP, ICH E6(R3), and relevant clinical research regulations and guidelines.
• Demonstrated experience with CAPA management, root cause analysis, preventive actions, and tracking commitments to completion.
• Experience with clinical development risk management, Quality by Design, and risk-based quality planning.
• Ability to work cross-functionally with clinical operations, quality assurance, regulatory, data management, and other clinical development teams.
• Strong communication, leadership, conflict resolution, analytical, strategic thinking, and problem-solving skills.

Nice to have

• Lean Six Sigma or PMP certification.
• Experience with Veeva or similar document and quality management systems.

Culture & Benefits

• 401(k) plan with company matching.
• Medical, dental, and vision insurance, with most or all premiums covered by hirify.global.
• Mental health and wellness benefits, life and AD&D insurance, and enhanced parental leave.
• Generous paid time off, holiday policies, and weeklong summer and winter holiday shutdowns.
• Daily subsidized lunch when working onsite.
• Bonus and equity compensation in addition to base salary.