Senior Associate Quality Compliance (AI)

Location: United States - Remote

Salary: USD 89,168.40–120,639.60 per year

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Strengthen and advance the R&D Quality Management System for products in clinical development.
• Enter audit responses and site inspection data into quality and inspection management systems.
• Coordinate deviation owners, CAPA development and closure, objective evidence, and potentially reportable serious breach documentation.
• Prepare weekly compliance metric reports covering deviations, CAPAs, serious breaches, audits, and inspection findings.
• Facilitate Rare Disease meetings, maintain decision and action logs, manage Q&A tracking, and support inspection readiness.
• Apply AI tools to streamline workflows, automate processes, improve operational efficiency, and support data-driven decisions.

Requirements

• Master’s degree, or a bachelor’s degree with 2 years of scientific or healthcare-related experience, or equivalent education and experience combinations.
• Knowledge and application of international Good Clinical Practice requirements is required.
• Understanding of clinical R&D activities, global regulations, R&D processes, and inspection management procedures.
• Experience in GCP Quality Compliance is preferred; knowledge of Good Pharmacovigilance Practice or Good Laboratory Practice is also relevant.
• Knowledge of ICH E6R3 and applicable 21 CFR regulations, including Parts 11, 50, 54, 56, 58, 312, and 812.
• Strong written and verbal communication, interpersonal skills, attention to detail, flexibility, and proficiency in Microsoft Office.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable.

Hiring process

• Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
• Sponsorship for this role is not guaranteed.