Quality Specialist (GxP)

Location: United States; remote work is supported, with hybrid office work encouraged for new hires located within a reasonably short commute of an office.

Company

hirify.global provides consulting solutions across the pharmaceutical, biotech, and medical device product lifecycle, including regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology.

What you will do

• Maintain compliance with relevant GxP guidelines and regulations.
• Support eQMS activities, including change control, deviations, quality events, CAPAs, and effectiveness checks.
• Develop, review, approve, monitor, and communicate root-cause analyses and CAPA plans.
• Participate in GxP change management, including risk and impact analysis, change plans, implementation, and completion tracking.
• Coordinate client audits and regulatory inspections, including agendas, documentation, logistics, subject matter experts, and CAPA responses.
• Prepare quality reports, analyze quality KPIs and event data, and retrospectively evaluate medical information telephone skills and case reports.

Requirements

• Fluent English speaking and writing.
• Knowledge and experience working with GxP quality management systems.
• Proficiency with Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.
• Strong organization, prioritization, project management, delegation, multitasking, and attention-to-detail skills.
• Excellent verbal, written, interpersonal, and customer service skills for working with clients, quality staff, and internal stakeholders.
• Ability to collaborate across departments, adapt to changing needs, and work proactively with minimal supervision.

Culture & Benefits

• Full-time employment.
• Remote working is supported.
• Hybrid office work may be arranged for employees who live within a reasonably short commute of an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Recruitment applications are personally reviewed, with an outcome provided to every applicant.