Director, Data Management Process, Quality & Inspection Readiness (Clinical Data Management)

Location: Warren, NJ; Tarrytown, NY; or Armonk, NY. Four days per week onsite; 25% travel may be required.

Salary: $183,100–$305,200 annually

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

• Lead Data Management quality, compliance, inspection readiness, audit support, and process governance.
• Develop quality frameworks covering CRO oversight, issue management, escalation, CAPA, risk reviews, and effectiveness checks.
• Direct preparation, coordination, response, and functional representation for health authority inspections.
• Establish KPI and KQI frameworks to monitor data quality, compliance, operational performance, and continuous improvement.
• Own Data Management process development, change management, training frameworks, documentation, and SharePoint repositories.
• Manage, mentor, and develop direct reports while leading cross-functional and subject matter expert networks.

Requirements

• Bachelor’s degree in Science, Health, Computing, or a related field.
• 12+ years of Clinical Data Management experience in biotechnology, pharmaceutical, or health-related industries.
• 5+ years of people management, leadership, and mentoring experience.
• Expert knowledge of clinical data management, GCP, ICH guidelines, 21 CFR Part 11, ALCOA+ principles, and global regulatory requirements.
• Experience supporting multiple FDA, PMDA, MHRA, EMA, or other health authority inspections, including preparation, response coordination, remediation, and functional representation.
• Strong experience with quality management systems, CAPA, issue management, process improvement, KPI/KQI frameworks, and organizational change management.

Culture & Benefits

• Inclusive workplace with a focus on accountability, collaboration, continuous improvement, and quality.
• Competitive total rewards package that may include annual bonuses, equity awards, retirement benefits, 401(k) matching, insurance, paid time off, and family support benefits.
• Onsite collaboration is expected for many roles.