Quality Compliance Specialist

TransPerfect is sourcing this role on behalf of our client, a contract research organization (CRO). This is a full-time, permanent position with the client. Candidates will apply through TransPerfect. Position Overview - Type: Full-time, permanent hire - Level: Mid-level quality compliance specialist - Location: Maryland-based. Hybrid, with 3 days per week in the office. - Environment: The client does not have a large QA department. The role calls for independence and ownership. Key Responsibilities Process and SOP Development - Write SOPs, work instructions, and processes from scratch. This role builds processes, not just reviews existing ones. - Work directly with the clinical team to put practical processes in place, not complicated procedures nobody follows. GCP Compliance and Auditing - Monitor and maintain day-to-day GCP compliance across all active studies. - Conduct regular internal audits of trial master files (TMF), site files, and vendor documentation. Identify gaps and make sure they are addressed before they become bigger issues. - Investigate audit findings, write responses, and develop CAPAs. Follow through to confirm issues are actually fixed. - Review quality-critical documents, including protocols, informed consent forms, and monitoring plans. Inspection Readiness - Lead inspection-readiness activities. - Serve as a point of contact during health authority inspections and sponsor audits. Quality Oversight and Training - Understand both the site and CRO sides of the business, including decentralized trial models and vendor oversight. - Track and report quality metrics and KPIs to leadership. - Deliver GCP and compliance training to staff and site personnel. - Serve as the team's point person on data integrity (ALCOA+). Minimum Qualifications - Bachelor's degree in life sciences, health sciences, or a related field. - 4–7 years in clinical quality assurance or GCP compliance, with direct, hands-on audit and documentation experience. - Strong working knowledge of ICH-GCP and FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312). - Demonstrated ability to write SOPs and build processes independently, not just review existing ones. - Experience with CAPA systems, TMF management, and writing audit findings and responses. - Comfortable working independently and taking ownership. Preferred Qualifications - Experience with decentralized clinical trials and vendor/CRO oversight. - Experience leading or hosting health authority inspections. - Experience in a small biotech or CRO environment, wearing multiple hats. About TransPerfect TransPerfect is a global leader in language and technology solutions. It is sourcing this role on behalf of its client. Interested candidates should apply through TransPerfect.