Clinical Quality Operations Manager (Biotech)

Location: Onsite at least 3 days per week in Millbrae, California or Jersey City, New Jersey

Salary: $143,000–$173,250 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 technologies combining chemistry, engineering, computation, and biology.

What you will do

• Execute operational quality management and inspection-readiness activities across assigned clinical 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 quality signals, trends, emerging risks, and process improvement opportunities.
• Monitor vendor and CRO performance against quality expectations and escalate compliance or inspection-readiness risks.
• Partner with Clinical Quality Assurance and cross-functional study teams on inspection preparation, regulatory developments, and operational standards.
• Lead CAPA implementation, coordinate process-change training, and contribute to quality procedures, tools, templates, policies, and SOPs.

Requirements

• 6+ years of related experience with a bachelor’s degree, or 4+ years with a postgraduate degree.
• Strong working knowledge of GCP, ICH E6(R3), and relevant clinical development regulations and guidelines.
• Experience with CAPA management, root cause analysis, preventive actions, and tracking corrective commitments to completion.
• Experience with clinical development risk management, quality planning, quality by design, and risk-based approaches.
• Ability to work cross-functionally with clinical operations, quality assurance, regulatory, data management, and other clinical development teams in a matrixed environment.
• Strong communication, teamwork, leadership, conflict-resolution, analytical, strategic, 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 substantial company premium coverage.
• Mental health and wellness benefits, enhanced parental leave, life and AD&D insurance.
• Generous paid time off, holiday policies, and weeklong summer and winter shutdowns.
• Daily subsidized lunch program when working onsite.
• Bonus and equity compensation are included in the overall employee compensation package.