GxP Document Control & Quality Systems Lead

Bicara Therapeutics; Boston (MA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Bicara Therapeutics is seeking a Manager, GxP Document Control to oversee and continually improve document control operations and quality systems coordination. You will lead cross-functional teams to balance speed, accuracy, and compliance, coaching authors and reviewers on clear, audit-ready procedures.

The role is based in our Boston office with a hybrid schedule (three in-office days per week). You will also support training administration, vendor coordination, and quality systems activities

Qualifications

• Bachelor's degree in a scientific discipline or equivalent combination of education and relevant industry experience.
• 5+ years of experience in Quality Assurance or Quality Systems, with at least 3 years in Document Control within the biotechnology, pharmaceutical, or other regulated industry.
• Demonstrated ability to critically review procedural content for internal consistency, cross-document alignment, and adherence to content standards.
• Experience coaching or training authors on SOP writing best practices and facilitating live comment-resolution sessions with cross-functional reviewers.
• Advanced Microsoft Word technical skills, including use of styles and form fields to build efficient, fillable document templates.
• Intermediate skills with Visio to develop process flow diagrams, and PDF fillable form generation.
• Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and timelines in a high-volume, fast-paced environment.
• Experience supporting quality systems activities such as audits, training management, inspection readiness, and quality metrics reporting.
• Strong attention to detail with the ability to work both independently and collaboratively across functions.
• Excellent written and verbal communication skills; comfortable acting as a go-to resource for stakeholders across the organization.

Responsibilities

• Lead day-to-day document control activities within the electronic QMS, including template and document development, formatting, routing, review, approval, issuance, revision, archival, and retirement of controlled documents (SOPs, forms, templates, logs) in accordance with company procedures and applicable GxP requirements.
• Critically read document content to ensure quality standards are met, including cross-document alignment and consistency across related documents (e.g. SOP and Forms).
• Coach authors and reviewers on writing clear, compliant, and usable SOPs; train users on best practices.
• Support form design for clear data capture and efficient authoring.
• Assist in timely comment resolution; schedule live review sessions and edit documents collaboratively.
• Apply Word and PDF techniques to create fillable forms and streamlined templates.
• Use Visio to develop and maintain process flow diagrams supporting SOPs and quality processes.
• Track document status in the eQMS and pull reports for visibility.

Skills

Quality systems

Document control

Cross-functional collaboration

Training & coaching

GxP compliance

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Word

Visio

PDF form design

Job description

Bicara Therapeutics is seeking a Manager, GxP Document Control to oversee and continually improve document control operations and quality systems coordination. You will lead cross-functional teams to balance speed, accuracy, and compliance, coaching authors and reviewers on clear, audit-ready procedures.

The role is based in our Boston office with a hybrid schedule (three in-office days per week). You will also support training administration, vendor coordination, and quality systems activities