Senior Director, GxP Quality Management Systems (QMS)

Position Overview Bicara Therapeutics is seeking a Senior Director, Quality Management Systems (QMS), reporting to the VP, Global Quality, to build and lead the company’s QMS from the ground up. This hands-on leadership role will establish a scalable, phase-appropriate quality framework that supports all GxP activities while driving speed, operational efficiency, and sustained inspection readiness. As a key member of the Quality leadership team, this individual will partner closely with GMP and GCP Quality leaders to design and implement pragmatic, risk-based processes and a fit-for-purpose operating model. The role is accountable for establishing robust systems, governance, and tools that support effective execution, while preserving the agility required to scale alongside organizational growth across clinical and commercial activities. This role is ideal for a leader who excels in a fast-paced, build-mode environment, balancing strategic vision with hands-on execution. The successful candidate brings a collaborative, solutions-oriented approach to partnering across Quality and cross-functional teams and will embed quality into the company’s operating model—fostering accountability, simplicity, and continuous improvement as the organization grows. This role is based in Boston with a hybrid schedule (three days onsite per week); however, a remote schedule may be considered. Responsibilities QMS Leadership - Design, implement, and continuously improve an integrated QMS to support all GxP activities at Bicara - Partner with GMP and GCP Quality leads to build practical, fit-for-purpose processes - Lead the establishment of QMS governance, driving consistent and effective use of quality systems across the organization - Collaborate with IT, Quality leaders and other internal stakeholders to implement electronic systems to support Bicara’s QMS Quality Systems - Develop and oversee core QMS processes, including deviations, CAPA, change control, document control, training, risk management, audits, and Quality Management Review (QMR) - Ensure systems are simple, effective, and aligned with how teams operate - Lead or support selected QMS activities (e.g., QMR, audits, inspections) in collaboration with Quality leads Inspection Readiness - Establish frameworks and tools to support ongoing inspection readiness - Partner with GMP and GCP Quality leads to establish inspection readiness strategies, carrying out planning and preparation activities, and inspection execution - Provide coordination and project management for inspections and related activities Operational Effectiveness - Ensure global processes, training, and tools remain aligned with regulatory requirements, industry expectations, and are fit for purpose - Define and monitor key quality metrics and trends and collaborate with quality and operational leads to establish governance forums to drive continuous improvement - Support management review processes and the identification of systemic risks across the quality management system. Work with process owners and stakeholders to mitigate these risks. - Drive adoption and optimization of eQMS tools and the integration and continuous improvement across QMS processes Qualifications - Bachelor’s degree in life sciences or related industry experience. - 10+ years of experience in GxP Quality (GMP and/or GCP) within biotech/pharma - Proven experience building and/or managing GxP Quality Management Systems including implementation of electronic systems for QMS. - Direct experience supporting and participating in global regulatory inspections, including pre-approval inspections. - Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders. - Detail-oriented mindset with a proactive approach to problem-solving and decision-making. - Experience working in a fast-paced, growing or evolving organization - Strong collaboration and influencing skills across fu