Director – Quality

Secura Bio, Inc.

Director/Senior Director of Quality leading GxP activities for an oncology-focused company. Ensuring compliance and managing quality systems across commercial and clinical operations.

Posted 5/20/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead day-to-day Quality operations, overseeing GxP activities to support commercial manufacturing and ongoing clinical trials, including compliance support and issue management
Own and manage the Quality Management System (QMS), ensuring compliance with global regulatory standards and alignment with corporate goals
Develop and oversee CAPA plans in response to Quality events, audits, and inspections; monitor CAPA effectiveness and closure
Manage quality oversight of CMOs, CROs, and other vendors; coordinate external audits and ensure effective supplier qualification and monitoring
Implement and maintain quality metrics, systems, and documentation associated with commercial product supply and clinical trials, including procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency
Provide leadership and strategic direction across Quality functions including Quality Systems, QA Operations, Supplier Quality, and Clinical Quality
Partner with Regulatory Affairs, CMC, Clinical, Supply Chain, and other cross-functional teams to ensure end-to-end GxP compliance
Drive continuous improvement initiatives to optimize quality processes, risk management, and inspection readiness
Serve as the point person for inspection readiness and regulatory agency inspections related to quality systems

Requirements

What you’ll need

Advanced degree (Ph.D., Pharm.D., M.D.) or Bachelor's/Master's degree with relevant experience in life sciences, pharmacy, or related field
10+ years of progressive experience in clinical quality assurance/quality control in the biotech/pharmaceutical industry
3+ years in leadership roles managing QA teams
Experience engaging with regulatory agencies (FDA, EMA, etc.)
Deep understanding of GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), all other related GxP requirements, ICH guidelines, and global regulatory requirements
Experience with clinical trial quality management systems
Knowledge of clinical data management and integrity practices
Familiarity with risk-based quality management approaches
Understanding of CMC (Chemistry, Manufacturing and Controls) as it relates to clinical development

Benefits

Comp & perks

Health insurance
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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

Hard Skills & Tools

Quality Management System (QMS)CAPA (Corrective and Preventive Action)GMP (Good Manufacturing Practice)GCP (Good Clinical Practice)GxP (Good Practice)ICH guidelinesclinical trial quality management systemsclinical data managementrisk-based quality managementCMC (Chemistry, Manufacturing and Controls)

Soft Skills

leadershipstrategic directioncross-functional collaborationcontinuous improvementissue managementcommunicationproblem-solvingorganizational skillsteam managementinspection readiness

Certifications

Ph.D.Pharm.D.M.D.