Associate Director, Quality Complaints Management
Amneal Pharmaceuticals LLC, Piscataway, NJ, United States
Description
This role is responsible for leading the global strategy, governance, and operational execution of the company's product complaint system for drug, biologic, and combination-product portfolios. This role ensures all complaints are received, evaluated, investigated, trended, and reported in full compliance with global health authority regulations and internal quality standards. As the Global Process Owner, this role drives harmonization, inspection readiness, data integrity, and cross‑functional collaboration to strengthen post‑market quality surveillance worldwide.
Essential Functions
Owns and maintains the global complaint handling process, policies, and SOPs across all regions and product lines. Ensures alignment with global regulations (21 CFR 211/820, EU GMP, ICH Q9, local HA requirements) and company quality systems. Leads standardization, continuous improvement, and global training initiatives.
Leads global complaint intake, triage, investigation, and closure processes with defined SLAs. Ensures robust root cause analysis, avoiding superficial “human error” conclusions, and drives effective CAPA. Partners with Manufacturing, QC, Engineering, Medical Safety, and CMOs for timely and thorough investigations.
Regulatory Compliance & Inspection Readiness. Serve as primary SME for FDA, EMA, MHRA, and other HA inspections related to complaint handling. Oversee regulatory reportability assessment and coordination (e.g., FARs, MDR/Vigilance for combination products, safety reporting with PV). Ensure high‑quality documentation, investigation records, and risk assessments.
Systems Ownership & Data Integrity. Act as Business Owner for the global complaint management system (e.g., Caliber, IRMS). Ensure validated, compliant workflows, strong data integrity (ALCOA), and reliable global reporting. Drive system enhancements to improve efficiency, traceability, and signal detection.
Trending, Metrics & Quality Insights. Develop and manage global dashboards and KPIs: complaint rates, aging/backlog, closure time, trend signals. Present complaint trends and risk insights to Global QA leadership, Quality Council, and Management Review. Escalate emerging risks, recurring issues, or signals requiring field action or process redesign.
Cross‑Functional Leadership. Partner globally with Pharmacovigilance, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams. Manage interactions with CMOs and suppliers for complaint‑related investigations and data sharing. Represent Complaint Management in global governance forums and lifecycle management activities.
People Leadership. Lead and develop a global team of complaint specialists, investigators, and analysts. Build competencies in investigation quality, critical thinking, medical/technical assessment, and risk‑based decision making. Promote a culture of transparency, learning, and continuous improvement.
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Essential Functions
Owns and maintains the global complaint handling process, policies, and SOPs across all regions and product lines. Ensures alignment with global regulations (21 CFR 211/820, EU GMP, ICH Q9, local HA requirements) and company quality systems. Leads standardization, continuous improvement, and global training initiatives.
Leads global complaint intake, triage, investigation, and closure processes with defined SLAs. Ensures robust root cause analysis, avoiding superficial “human error” conclusions, and drives effective CAPA. Partners with Manufacturing, QC, Engineering, Medical Safety, and CMOs for timely and thorough investigations.
Regulatory Compliance & Inspection Readiness. Serve as primary SME for FDA, EMA, MHRA, and other HA inspections related to complaint handling. Oversee regulatory reportability assessment and coordination (e.g., FARs, MDR/Vigilance for combination products, safety reporting with PV). Ensure high‑quality documentation, investigation records, and risk assessments.
Systems Ownership & Data Integrity. Act as Business Owner for the global complaint management system (e.g., Caliber, IRMS). Ensure validated, compliant workflows, strong data integrity (ALCOA), and reliable global reporting. Drive system enhancements to improve efficiency, traceability, and signal detection.
Trending, Metrics & Quality Insights. Develop and manage global dashboards and KPIs: complaint rates, aging/backlog, closure time, trend signals. Present complaint trends and risk insights to Global QA leadership, Quality Council, and Management Review. Escalate emerging risks, recurring issues, or signals requiring field action or process redesign.
Cross‑Functional Leadership. Partner globally with Pharmacovigilance, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams. Manage interactions with CMOs and suppliers for complaint‑related investigations and data sharing. Represent Complaint Management in global governance forums and lifecycle management activities.
People Leadership. Lead and develop a global team of complaint specialists, investigators, and analysts. Build competencies in investigation quality, critical thinking, medical/technical assessment, and risk‑based decision making. Promote a culture of transparency, learning, and continuous improvement.
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