Senior Director, GxP Quality Management Systems

Bicara Therapeutics

Senior Director leading quality management systems for GxP activities at Bicara Therapeutics. Building scalable frameworks and collaborating with cross-functional quality teams in a hybrid work environment.

Posted 5/22/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $254,000 - $295,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Build and lead the company’s QMS from the ground up
Design, implement, and continuously improve an integrated QMS to support all GxP activities
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
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
Establish frameworks and tools to support ongoing inspection readiness
Provide coordination and project management for inspections and related activities
Define and monitor key quality metrics and trends and collaborate with quality and operational leads to establish governance forums to drive continuous improvement
Drive adoption and optimization of eQMS tools and the integration and continuous improvement across QMS processes

Requirements

What you’ll need

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

Benefits

Comp & perks

Medical coverage
Dental coverage
Vision coverage

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Management SystemsGxPGMPGCPCAPAchange controldocument controlrisk managementauditsQuality Management Review

Soft Skills

communicationinterpersonal skillsproblem-solvingdecision-makingcollaborationinfluencingdetail-orientedorganizational skillsleadershipflexibility