Senior Manager, GCP, GLP Supplier Quality (Biotech)

Location: Fully remote; can be performed from anywhere. Occasional travel for team meetings or events and frequent domestic/international travel of up to 20% are expected.

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 qualification, onboarding, risk assessment, and lifecycle management for GCP and GLP suppliers and service providers.
• Collaborate with procurement, supply chain, DevQA, and subject matter experts on supplier selection, qualification strategies, and performance evaluation.
• Maintain the approved supplier list, qualification records, risk-based controls, escalation programs, and supplier governance forums.
• Develop and improve supplier performance monitoring frameworks, including KPIs, scorecards, quality metrics, and risk-based scoring.
• Manage supplier quality events and continuous improvement activities, including deviations, investigations, change controls, and CAPAs.
• Own the global GCP/GLP Quality Technical Agreement program, including negotiation, execution, maintenance, review, and renewal of Quality Agreements.

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, including supplier oversight, audits, qualification, Quality Agreements, CAPA management, and risk management.
• Deep knowledge of ICH GCP guidelines, data integrity principles, risk management methodologies such as RBQM, and global GCP regulations.
• Working knowledge of FDA, EMA, MHRA, PMDA, and Health Canada inspection and clinical trial requirements, including relevant 21 CFR, ICH, EU, and GLP frameworks.
• Strong data analytics, critical thinking, decision-making, and supplier audit capabilities.

Nice to have

• Certification in GCP auditing or clinical research.
• Experience with GLP regulations, laboratory compliance frameworks, and computerized systems expectations.
• Experience working in global clinical development environments.

Culture & Benefits

• Fully remote work with purposeful in-person collaboration and support for occasional team meetings and events.
• 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, LinkedIn Learning access, workshops, leadership development, mentorship, networking, employee resource groups, and service programs.