Manager, GxP Document Control and Quality Systems

Bicara Therapeutics is seeking a Manager, GxP Document Control who will manage and continuously improve document control operations and quality systems coordination for Bicara Therapeutics. Reporting to the Sr. Director, GxP Quality Management Systems, this role is expected to critically read and evaluate procedural content, ensure consistency and technical accuracy within and across controlled documents, and coach authors and reviewers on writing clear, followable, audit-ready procedures. The Manager will lead cross-functional teams through a high-volume, dynamic period of document generation, balancing speed, accuracy, fit-for-purpose judgment, and compliance. The role also provides general quality systems function support, including GxP Training program administration, vendor and clinical site audit coordination, and serves as a flexible, go-to resource across the Quality organization.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

• 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.

• As part of Document Control processing, critically read document content to ensure quality standards are met, including:

  • Ensuring details within different sections of the same document are accurate, consistent and aligned with content standards.

  • Ensuring details are accurate, aligned, and consistent across related documents (i.e. SOP and Forms).

  • Holding authors accountable to established document content and processing standards; able to clearly articulate what must be done and why.

• Serve as an internal trainer/coach, teaching authors and reviewers best practices for writing clear, compliant, and usable SOPs.

• Be a resource for form design for clear, efficient, and accurate data capture.

• Support authors in driving timely comment resolution; for example, scheduling live review sessions and editing documents on-screen in real time with the team to reach consensus efficiently.

• Manage periods of high document volume, including:

  • Prioritizing based on business need and risk.

  • Applying project management skills to ensure related groups of documents move through the process together and in line with established due dates.

  • Apply Word & PDF technical skills (e.g., styles, form fields) to make authoring and formatting more efficient, and to build fillable form versions for use by SMEs.

• Use Visio to develop and maintain process flow diagrams supporting SOPs and quality processes.

• Track document status and progress within the eQMS and pull reports as needed to support team and management visibility.

• Assess and determine training assignments by applying established criteria.

• Perform training administration tasks within the eQMS; assigning training roles to users, managing curriculum assignments, maintaining training content, pulling training reports.

• Provide administrative and coordination support with scheduling and correspondence to facilitate communication between internal teams, vendors, clinical sites, and auditors in support of audit program execution, such as:

  • Sending questionnaires to vendors.

  • Following up on due dates for items like audit agendas, draft audit reports, and auditee responses.

  • Updating audit status in the applicable tracker/system.

• Filing final GxP records in designated repositories following established conventions, ensuring accurate identification and retrievability.

• Performing data/document review as part of assigned gap assessments.

• Support regulatory inspection logistical execution and inspection readiness initiatives.

• Executes at a high level independently once direction has been provided; knows when to proactively seek clarification or additional guidance.

• Communicates clearly, concisely, and professionally with internal and external stakeholders; comfortable serving as the go-to resource and face of the function for end-user support.

• Understands how to operate in a dynamic, transitional environment balancing speed, accuracy, fit-for-purpose judgment, and compliance.

• 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.

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.