CQA Team Leader

Location: Remote, United States; US and Puerto Rico residents only

Salary: $133,500–$192,833 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through immunoscience, digital research, and AI-powered technologies.

What you will do

• Lead, coach, and develop a team of clinical quality auditors and business support staff.
• Plan and oversee risk-based clinical audits, including audit scope, scheduling, execution, reporting, and follow-up.
• Provide GCP consultation and support clinical projects, quality reviews, workgroups, and regulatory interpretation.
• Coordinate and participate in regulatory inspection activities, including preparation, inspection support, hosting, and post-inspection follow-up.
• Use predictive analytics and real-time data insights to identify, assess, and escalate clinical trial risks.
• Improve quality processes and digital workflows using AI, machine learning, data quality controls, and digital tools.

Requirements

• Bachelor’s degree in life sciences, medical sciences, natural sciences, or a related discipline, or equivalent experience.
• At least 10 years of relevant experience with a bachelor’s degree, or 5 years with an advanced degree.
• At least 5 years of experience in Clinical Quality Assessment and/or clinical trials, including monitoring or clinical trial management.
• Extensive knowledge of international clinical regulations, guidelines, and Good Practices, including ICH/GCP.
• Experience managing technical or scientific staff, with strong leadership, coaching, communication, and decision-making skills.
• Good business communication skills in English, proficiency with clinical trial management systems, eClinical platforms, data visualization tools, and digital collaboration platforms.

Culture & Benefits

• Supportive, future-focused environment centered on scientific progress and clinical quality.
• Opportunities for career growth through promotion, lateral moves, and international development.
• Employee rewards and benefits, including healthcare, prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Collaboration across scientific, clinical, and digital teams to improve drug development.