Sr Specialist QA - Compliance (Biotech)

Location: West Greenwich, Rhode Island, United States

Company

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

What you will do

• Coordinate regulatory inspections, corporate, internal, and customer audits across two manufacturing facilities.
• Maintain continuous inspection readiness for a multi-product GMP manufacturing operation.
• Develop and improve inspection-readiness programs, tools, trackers, playbooks, and governance processes.
• Lead readiness planning, mock inspections, war-room preparation, document retrieval, interview preparation, and daily inspection management.
• Track commitments, actions, deliverables, risks, and remediation activities, escalating significant issues to quality and senior leadership.
• Coordinate inspection narratives, site presentations, data packages, response plans, and cross-functional issue resolution.

Requirements

• High school diploma/GED with 12 years of regulatory compliance experience, or an associate degree with 10 years, bachelor's degree with 6 years, master's degree with 4 years, or doctorate with 2 years of experience.
• Experience preparing for, participating in, and responding to Health Authority inspections.
• 7+ years of related experience in pharmaceutical manufacturing, process development, or quality assurance, with progressively increasing responsibility.
• Thorough knowledge of EU and US cGMP requirements, quality management systems, and quality control processes.
• Experience with bulk drug substance manufacturing, compliance, data analysis, project management, and cross-functional leadership.
• Ability to work autonomously, communicate effectively, organize data logically, and solve complex problems in ambiguous situations.

Culture & Benefits

• Collaborative, innovative, and science-based working culture focused on serving patients.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Discretionary annual bonus program and award-winning paid time-off plans.
• Career development opportunities and 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.