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Open nowPosted 5 hours ago

Quality Compliance Specialist

TransPerfect676 open roles

Where
Washington DC, Maryland, United States
Work mode
Hybrid
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Your applicationOpen nowQuality Compliance SpecialistTransPerfect · Washington DC, Maryland, United States

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The clock on this job

Early applications get read.

13.7% of postings close within 7 days. Measured by our own scanner across the market. TransPerfect postings stay open a median of 45 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.8%3 days
  3. 13.7%7 days
  4. 22.1%14 days
  5. 37.6%30 days
  6. 59.1%60 days
This job: posted 5 hours ago

TransPerfect median: 45 days open

The posting

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.

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