Senior Manager, GCP/GLP Supplier Quality

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events is expected, with frequent domestic and international travel of up to 20% based on supplier requirements.

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 supplier qualification, onboarding, risk assessment, selection, and lifecycle management for GCP and GLP suppliers and service providers.
• Administer the Supplier Management Program, maintain approved supplier records, and govern risk-based controls throughout the supplier lifecycle.
• Develop and improve supplier performance monitoring frameworks, including KPIs, scorecards, quality metrics, and risk-based scoring.
• Manage supplier quality events, deviations, investigations, change controls, CAPAs, escalations, and continuous improvement activities.
• Analyze supplier quality trends, audit findings, inspection outcomes, data integrity issues, and remediation actions with cross-functional stakeholders.
• Own the global GCP/GLP Quality Technical Agreement program and support supplier audits, inspection readiness, and Health Authority inspections.

Requirements

• Bachelor’s degree in Chemistry, Engineering, Life Science, or a related discipline.
• 12–15 years of direct experience supporting GCP and/or GLP regulated activities.
• Strong experience managing supplier quality programs for clinical and nonclinical outsourced service providers.
• Demonstrated experience with GCP and GLP supplier oversight, audits, supplier qualification, quality agreements, CAPA management, and risk management.
• Deep understanding of ICH GCP guidelines, data integrity principles, and risk-based quality management methodologies.
• Working knowledge of global GCP regulations and guidelines, including FDA, ICH, EU, MHRA, EMA, and Health Canada requirements.

Nice to have

• Understanding of GLP regulations and laboratory compliance frameworks, including FDA 21 CFR Part 58 and OECD Principles of GLP.
• Certification in GCP auditing or clinical research.
• Experience working in global clinical development environments.

Culture & Benefits

• Fully remote work with connection to the hirify.global community and occasional purposeful in-person collaboration.
• 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.
• 401(k) plan with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
• Learning programs, mentorship, networking opportunities, employee resource groups, and service and recognition programs.