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.