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
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Type: Full-time, permanent hire
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Level: Mid-level quality compliance specialist
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Location: Maryland-based. Hybrid, with 3 days per week in the office.
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Environment: The client does not have a large QA department. The role calls for independence and ownership.
Key Responsibilities
Process and SOP Development
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Write SOPs, work instructions, and processes from scratch. This role builds processes, not just reviews existing ones.
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Work directly with the clinical team to put practical processes in place, not complicated procedures nobody follows.
GCP Compliance and Auditing
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Monitor and maintain day-to-day GCP compliance across all active studies.
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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.
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Investigate audit findings, write responses, and develop CAPAs. Follow through to confirm issues are actually fixed.
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Review quality-critical documents, including protocols, informed consent forms, and monitoring plans.
Inspection Readiness
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Lead inspection-readiness activities.
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Serve as a point of contact during health authority inspections and sponsor audits.
Quality Oversight and Training
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Understand both the site and CRO sides of the business, including decentralized trial models and vendor oversight.
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Track and report quality metrics and KPIs to leadership.
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Deliver GCP and compliance training to staff and site personnel.
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Serve as the team's point person on data integrity (ALCOA+).
Minimum Qualifications
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Bachelor's degree in life sciences, health sciences, or a related field.
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4–7 years in clinical quality assurance or GCP compliance, with direct, hands-on audit and documentation experience.
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Strong working knowledge of ICH-GCP and FDA regulations (21 CFR Parts 11, 50, 54, 56, and 312).
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Demonstrated ability to write SOPs and build processes independently, not just review existing ones.
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Experience with CAPA systems, TMF management, and writing audit findings and responses.
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Comfortable working independently and taking ownership.
Preferred Qualifications
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Experience with decentralized clinical trials and vendor/CRO oversight.
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Experience leading or hosting health authority inspections.
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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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