Quality Compliance Specialist

Key Responsibilities

• Maintain and manage audit- and inspection-related records throughout the audit lifecycle
• Support inspection readiness activities across multiple projects in development and commercial stages
• Compile and analyze data for risk assessments related to audits, inspections, and suppliers
• Track audit observations, follow-up actions, and closures
• Maintain accurate inspection readiness data within eQMS, Veeva Audit Module, and Share Point
• Assist in the development and maintenance of standardized inspection readiness templates aligned with regulatory requirements
• Support internal and external stakeholders in monitoring supplier performance
• Track, trend, and report quality metrics related to supplier qualification, audits, and inspections
• Communicate project status and updates to management

• BS/BSc in Life Sciences, STEM, or related field
• 1–3+ years of QA, compliance, or audit-related experience in biotech, pharmaceutical, or regulated industries
• Working knowledge of GxP processes related to vendors, partners, and suppliers
• Familiarity with FDA regulations (21 CFR Parts 210 & 211), ICH guidelines, and US/EU regulatory requirements; ISO knowledge is a plus
• Experience organizing and maintaining audit and supplier documentation
• Strong attention to detail with solid investigation, problem-solving, and organizational skills
• Excellent written and verbal communication skills
• Ability to work effectively in ambiguous and fast-paced environments
• Strong stakeholder collaboration and data consolidation skills
• Proficient in Microsoft Office applications
• Ability to influence, recommend solutions, and support continuous improvement initiatives