Senior Specialist II, Quality Compliance & Client Liaison

Location: West Chester, Ohio, United States

Salary: $100,000–$143,750 per year

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for pharmaceutical and biotechnology products.

What you will do

• Lead site compliance processes, including Quality Client Management, Quality Agreements, and self-inspections.
• Serve as the primary quality liaison for pharmaceutical clients throughout the product lifecycle.
• Own Quality Agreements and attachments, coordinate revisions, and monitor compliance with client-specific requirements.
• Lead client quality review meetings, coordinate responses to quality inquiries, and support client quality visits.
• Manage the internal audit program, including planning, execution, reporting, metrics, and CAPA follow-up.
• Develop compliance SOPs and oversight tools, assess risks, and report quality trends and escalations to leadership and clients.

Requirements

• Strong knowledge of cGMP in the pharmaceutical or biotechnology industry.
• Knowledge of FDA, EU, and Japanese regulatory requirements, ICH/ISO guidelines, and applicable regulations including 21 CFR 210, 21 CFR 211, 21 CFR 600s, 21 CFR 820, ISO 13485, and Annex 1.
• Knowledge of aseptic and sterile manufacturing, inspection, packaging, labelling, and testing processes.
• Strong investigation, quality assurance problem-solving, leadership, project management, technical writing, communication, and influencing skills.
• Experience tracking and trending meaningful metrics and working independently with multidisciplinary teams.
• Work authorization or visa sponsorship is not available for this position.

Nice to have

• Bachelor’s degree in pharmacy, biology, chemistry, engineering, or another science or technical field.
• Advanced degree or MBA, extensive pharmaceutical QA or regulatory compliance experience, and experience leading regulatory inspections.
• Experience managing quality systems and compliance processes.
• ASQ certification such as CQA, CQE, or CQM.
• Experience with Quality Master Data systems such as SAP, Empower, or LIMS.

Culture & Benefits

• Monday–Friday work schedule, with overtime or schedule changes possible based on business needs.
• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, and vision coverage, life and disability insurance, and family-building benefits.
• Paid vacation, paid holidays, and other paid leaves of absence.
• Tuition reimbursement and caregiving support.