Sr. Quality Specialist, GxP Document Control
Bicara Therapeutics
August 11, 2026
Remote friendly (Boston, MA)
United States
$105,000 - $128,000 USD yearly
Operations
Responsibilities:
- Lead day-to-day document control activities within the electronic QMS (development, formatting, routing, review, approval, issuance, revision, archival, retirement of controlled documents including SOPs, forms, templates, and logs).
- Organize, maintain, and archive GxP documentation outside the formal QMS structure to ensure it is inspection-ready and easily retrievable.
- Serve as operational support for the GxP QMS function, partnering with GMP Operations & Supplier Management and Clinical GCP Quality.
- Develop and maintain training curriculum and GxP tracking; support administration of Deviation/CAPA, Change Control, Management Review, and inspection readiness.
- Support internal and external audit scheduling and logistics; track audit status and assist with follow-up.
- Develop and maintain quality metrics, dashboards, trackers, and trending tools (including Smartsheet and Microsoft Excel) for oversight, compliance monitoring, management review, and continuous improvement.
- Collaborate cross-functionally to support quality systems improvements and GxP compliance.
- Support additional Quality Systems initiatives as assigned.
Qualifications:
- Bachelor’s degree in a scientific discipline or equivalent combination of education and relevant industry experience.
- 5+ years in Quality Assurance, Quality Systems, or Document Control within a regulated industry.
- Experience in GxP-regulated environments (supporting GCP and/or GMP quality systems).
- Working knowledge of document control processes and eQMS.
- Experience supporting audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting.
- Strong proficiency in Microsoft Excel and experience with Smartsheet or similar tools.
- Strong organizational, analytical, and problem-solving skills; ability to manage multiple priorities.
- Strong attention to detail; able to work independently and collaboratively.
- Excellent written and verbal communication skills.
- Clinical-stage biotech/pharma experience preferred.
Compensation Range:
- $105K - $128K
- Lead day-to-day document control activities within the electronic QMS (development, formatting, routing, review, approval, issuance, revision, archival, retirement of controlled documents including SOPs, forms, templates, and logs).
- Organize, maintain, and archive GxP documentation outside the formal QMS structure to ensure it is inspection-ready and easily retrievable.
- Serve as operational support for the GxP QMS function, partnering with GMP Operations & Supplier Management and Clinical GCP Quality.
- Develop and maintain training curriculum and GxP tracking; support administration of Deviation/CAPA, Change Control, Management Review, and inspection readiness.
- Support internal and external audit scheduling and logistics; track audit status and assist with follow-up.
- Develop and maintain quality metrics, dashboards, trackers, and trending tools (including Smartsheet and Microsoft Excel) for oversight, compliance monitoring, management review, and continuous improvement.
- Collaborate cross-functionally to support quality systems improvements and GxP compliance.
- Support additional Quality Systems initiatives as assigned.
Qualifications:
- Bachelor’s degree in a scientific discipline or equivalent combination of education and relevant industry experience.
- 5+ years in Quality Assurance, Quality Systems, or Document Control within a regulated industry.
- Experience in GxP-regulated environments (supporting GCP and/or GMP quality systems).
- Working knowledge of document control processes and eQMS.
- Experience supporting audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting.
- Strong proficiency in Microsoft Excel and experience with Smartsheet or similar tools.
- Strong organizational, analytical, and problem-solving skills; ability to manage multiple priorities.
- Strong attention to detail; able to work independently and collaboratively.
- Excellent written and verbal communication skills.
- Clinical-stage biotech/pharma experience preferred.
Compensation Range:
- $105K - $128K