Manager, Product Quality Complaint Data Analytics (Biopharma)

Location: Bridgewater, New Jersey, United States; hybrid with onsite work at headquarters 3 days per week and 2 remote days

Salary: $124,000–$161,000 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead the Product Quality Complaint Analytics function, including reporting, metrics, trending, Veeva system support, process improvements, and Management Review reporting.
• Manage and develop a QA Senior Product Complaint Specialist, setting priorities, allocating resources, and overseeing delivery.
• Support complaint management for clinical and commercial drug, device, and combination products, including intake, evaluation, investigation, trending, and regulatory compliance.
• Develop statistical processes, analytical frameworks, automated reporting, data visualizations, KPIs, and action or alert thresholds.
• Support signal detection and quality decision-making, including escalation through investigations, CAPAs, and product assessments.
• Maintain global surveillance procedures, work instructions, and quality system documentation supporting FDA, 21 CFR 820, ISO 13485, and other requirements.

Requirements

• Bachelor’s degree in a related discipline and at least 8 years of experience in Quality Assurance, Product Quality, Post-Market Surveillance, or Product Quality Complaint Analytics.
• At least 3 years of experience leading a highly collaborative team.
• Experience with complaint handling, investigations, trending, product performance monitoring, statistical methods, and continuous improvement in a regulated industry.
• Experience managing projects, technical staff, and cross-functional initiatives, including deviations, CAPAs, and Management Review.
• Working knowledge of FDA Quality System Regulations, cGMPs, Good Documentation Practices, and ISO 13485.
• Ability to work onsite in Bridgewater, New Jersey, 3 days per week.

Nice to have

• Experience with Veeva Vault QMS, Qlik, Minitab, or similar analytics tools.
• Experience supporting new product launches and product quality activities across drug, device, and combination products.

Culture & Benefits

• Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) with company match, annual equity awards, Employee Stock Purchase Plan, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning, leadership development, mentorship, networking, employee resource groups, and service opportunities.