Associate Director, Global PV Product Complaint Management & Oversight

Location: Durham, North Carolina, United States; hybrid schedule with 3 days in the office and 2 days working from home each week

Company

hirify.global is a public benefit biotech and pharmaceutical company developing therapies for rare diseases and technologies to expand the availability of transplantable organs.

What you will do

• Lead global product complaint governance across drugs, devices, combination products, and biologics throughout the product lifecycle.
• Establish and maintain global policies, standards, procedures, process maps, escalation pathways, and role clarity for product complaint handling.
• Oversee end-to-end complaint operations, including safety database entry, quality system initiation, coding, MDRs, malfunction reports, FARs, and BPDRs.
• Evaluate regulatory changes and implement compliant process, system, governance, and training updates.
• Lead inspection readiness, audits, root cause analysis, deviations, CAPAs, and continuous improvement initiatives.
• Manage direct reports and collaborate with Quality Systems, IT, GPS Systems and Analytics, vendors, and cross-functional safety partners.

Requirements

• Bachelor’s degree in a related field or BSN; a master’s degree or PharmD is preferred.
• At least 12 years of pharmacovigilance or product complaint experience with a bachelor’s degree, 10 years with a master’s degree, or 7 years with a PharmD.
• Experience supporting devices, biologics, drug products, and combination products in local or global environments.
• Experience overseeing vendors and implementing product complaint processing under IMDRF and other regulatory guidance.
• Strong knowledge of cGMP, GDP, QSR, ISO 13485, ISO 14971, IEC 62304, ISO 10993, MedDRA, and global pharmacovigilance regulations.
• Experience with end-to-end case processing, safety databases such as Argus, project management, people management, and regulatory submissions.

Culture & Benefits

• Hybrid work arrangement with two work-from-home days each week.
• Medical, dental, vision, prescription, wellness, disability, and savings programs.
• 401(k), ESPP, paid time off, and paid parental leave.
• Work focused on unmet medical needs, rare diseases, and transplantable organ technologies.