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Descripción del empleo
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.