Job Description

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 drive effective CAPA. Partners with Manufacturing, QC, Engineering, Medical Safety, and CMOs for timely and thorough investigations.
• Regulatory Compliance & Inspection ReadinessServe 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 IntegrityAct 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 InsightsDevelop 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 LeadershipPartner 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.

Qualifications

Education:

• Bachelor's Degree (BA/BS) Science, biomedical, pharmaceutical - Required
• Master's degree (MS/MA) Pharmaceutical Science - Preferred

Experience:

• 10 years or more in Complaint Management within the Pharmaceutical or Medical Device Industry.
• 5 years or more in leading teams in a global or multi-site environment

Specialized Knowledge:

• Experience supporting FDA/EMA/MHRA inspections and owning major quality systems
• Strong Analytical, communication, stakeholder management, and decision-making skills
• In depth, specialized knowledge of risk assessment as it relates to quality complaints.

The salary for this position ranges from $170,000 to 185,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

About Us

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.