Quality Compliance Specialist
About The Position
TransPerfect is sourcing this full-time, permanent position on behalf of its client, a contract research organization (CRO). The role is Maryland-based and hybrid, with three days per week in the office. The client has a small QA department, so the position requires independence, ownership, and the ability to build practical quality processes from the ground up. The Quality Compliance Specialist develops SOPs, work instructions, and processes in close collaboration with the clinical team; maintains day-to-day GCP compliance across active studies; and conducts audits of trial master files, site files, and vendor documentation. The role investigates audit findings, writes responses, develops CAPAs, and follows through to verify that issues are resolved. It also reviews quality-critical documents, leads inspection-readiness activities, and serves as a point of contact during health authority inspections and sponsor audits. The specialist provides quality oversight and training, tracks and reports quality metrics and KPIs to leadership, and serves as the team's point person for data integrity (ALCOA+). The role requires understanding both site and CRO operations, including decentralized trial models and vendor oversight. Candidates apply through TransPerfect.
Requirements
- Bachelor's degree in life sciences, health sciences, or a related field.
- 4–7 years of experience in clinical quality assurance or GCP compliance, including 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, rather than only reviewing existing ones.
- Experience with CAPA systems, TMF management, and writing audit findings and responses.
- Comfort working independently and taking ownership.
Nice To Haves
- 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.
Responsibilities
- Write SOPs, work instructions, and processes from scratch.
- Work with the clinical team to establish practical processes.
- Monitor and maintain day-to-day GCP compliance across active studies.
- Conduct regular internal audits of trial master files, site files, and vendor documentation; identify gaps and ensure they are addressed.
- Investigate audit findings, write responses, develop CAPAs, and follow through to confirm issues are resolved.
- Review quality-critical documents, including protocols, informed consent forms, and monitoring plans.
- Lead inspection-readiness activities.
- Serve as a point of contact during health authority inspections and sponsor audits.
- 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+).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
