About this role
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.