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Senior Director, GxP Quality Management Systems
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-07-20
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-20
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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
- 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
Position Requirements
10+ Years
work experience
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