Manager, GxP Document Control and Quality Systems

Bicara Therapeutics • Boston, MA

12h • Hybrid

About The Position

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.

Requirements

• 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: 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).
• Hold 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 SOP.
• 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.
• File final GxP records in designated repositories following established conventions, ensuring accurate identification and retrievability.
• Perform data/document review as part of assigned gap assessments.
• Support regulatory inspection logistical execution and inspection readiness initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager