Sr. Quality Specialist, GxP Document Control
Bicara Therapeutics
June 30, 2026
Remote friendly (Boston, MA)
United States
$105,000 - $128,000 USD yearly
Operations
Position Overview
- Senior QA Specialist, GxP Document Control and Quality Systems. Hybrid (Boston; three days onsite/week; remote considered).
Responsibilities
- Lead day-to-day document control in the electronic QMS (development, formatting, routing, review/approval, issuance, revision, archival/retirement of controlled SOPs/forms/templates/logs) per company procedures and GxP.
- Organize, maintain, and archive GxP documentation outside the formal QMS for inspection readiness and easy retrieval.
- Support the GxP QMS function and partner with GMP Operations & Supplier Management and Clinical GCP Quality.
- Develop/maintain training curriculum and GxP tracking; support Deviation/CAPA, Change Control, Management Review, and inspection readiness.
- Support internal/external audit scheduling/logistics; track audit status and assist with follow-up.
- Build/maintain quality metrics, dashboards, trackers, and trending tools (Smartsheet, Microsoft Excel).
- Collaborate cross-functionally to improve quality systems and ensure GxP compliance (GCP/GMP).
- Support additional Quality Systems initiatives as assigned.
Qualifications
- Bachelor’s in a scientific discipline (or equivalent education + relevant experience).
- 5+ years in Quality Assurance, Quality Systems, or Document Control (biotech/pharma/regulated industry).
- Experience in GxP environments (GCP and/or GMP).
- Working knowledge of document control and eQMS.
- Experience with audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting.
- Proficiency in Microsoft Excel; experience with Smartsheet (or similar).
- Strong organization, analytical/problem-solving, attention to detail, and written/verbal communication.
- Clinical-stage biotech/pharma experience preferred.
Compensation Range
- $105K–$128K
- Senior QA Specialist, GxP Document Control and Quality Systems. Hybrid (Boston; three days onsite/week; remote considered).
Responsibilities
- Lead day-to-day document control in the electronic QMS (development, formatting, routing, review/approval, issuance, revision, archival/retirement of controlled SOPs/forms/templates/logs) per company procedures and GxP.
- Organize, maintain, and archive GxP documentation outside the formal QMS for inspection readiness and easy retrieval.
- Support the GxP QMS function and partner with GMP Operations & Supplier Management and Clinical GCP Quality.
- Develop/maintain training curriculum and GxP tracking; support Deviation/CAPA, Change Control, Management Review, and inspection readiness.
- Support internal/external audit scheduling/logistics; track audit status and assist with follow-up.
- Build/maintain quality metrics, dashboards, trackers, and trending tools (Smartsheet, Microsoft Excel).
- Collaborate cross-functionally to improve quality systems and ensure GxP compliance (GCP/GMP).
- Support additional Quality Systems initiatives as assigned.
Qualifications
- Bachelor’s in a scientific discipline (or equivalent education + relevant experience).
- 5+ years in Quality Assurance, Quality Systems, or Document Control (biotech/pharma/regulated industry).
- Experience in GxP environments (GCP and/or GMP).
- Working knowledge of document control and eQMS.
- Experience with audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting.
- Proficiency in Microsoft Excel; experience with Smartsheet (or similar).
- Strong organization, analytical/problem-solving, attention to detail, and written/verbal communication.
- Clinical-stage biotech/pharma experience preferred.
Compensation Range
- $105K–$128K