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Bicara Therapeutics, a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation, is seeking a Manager of GxP Document Control and Quality Systems. This role will manage and continuously improve document control operations and quality systems coordination, reporting to the Sr. Director of GxP Quality Management Systems.
You will 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 GxP requirements. You will critically read document content to ensure quality standards are met, verifying internal consistency within documents, cross-document alignment, and adherence to content standards. You will serve as an internal trainer and coach, teaching authors and reviewers best practices for writing clear, compliant, and usable SOPs, and support form design for efficient data capture.
You will manage periods of high document volume by prioritizing based on business need and risk, applying project management skills to ensure related document groups move through the process on schedule. You will use advanced Microsoft Word skills (styles, form fields) and Visio to develop process flow diagrams and fillable forms, making authoring and formatting more efficient. You will track document status and progress within the eQMS and pull reports to support team and management visibility.
Additional responsibilities include assessing and determining training assignments within the eQMS, providing administrative and coordination support for vendor and clinical site audits, filing final GxP records in designated repositories, performing data/document review as part of gap assessments, and supporting regulatory inspection readiness initiatives. You will execute independently once direction is provided, communicate clearly with internal and external stakeholders, and serve as the go-to resource for end-user support.
This role is based in the Boston office and follows a hybrid schedule with three in-office days per week.
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 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 ability to manage multiple priorities and timelines in 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 ability to work both independently and collaboratively across functions
- Excellent written and verbal communication skills
