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 functions

• Ability to balance structure with flexibility and evolve processes over time

• Clear, organized, and execution-focused leadership style

Company Overview

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.