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 based in Maryland and follows a hybrid schedule with three days per week in the office. The client has a small quality assurance department, so the specialist is expected to work independently, take ownership, and build practical quality processes in close collaboration with the clinical team. The specialist will develop SOPs, work instructions, and processes from scratch; maintain GCP compliance across active studies; conduct internal audits; investigate findings and develop CAPAs; review quality-critical documents; lead inspection readiness; and serve as a contact during health authority inspections and sponsor audits. The role also includes monitoring quality metrics, delivering GCP and compliance training, and advising the team on data integrity (ALCOA+).
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.
- Direct, hands-on audit and documentation experience.
- Strong working knowledge of ICH-GCP and FDA regulations, including 21 CFR Parts 11, 50, 54, 56, and 312.
- Demonstrated ability to write SOPs and build processes independently, rather than only reviewing existing processes.
- Experience with CAPA systems, TMF management, and writing audit findings and responses.
- Ability to work independently and take 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 practical processes from scratch in collaboration with the clinical team.
- 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 compliance gaps and ensure they are addressed.
- Investigate audit findings, write responses, develop CAPAs, and verify that corrective actions resolve the issues.
- 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
