Senior Director, GxP Quality Management Systems (QMS)

Responsibilities 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. Collaborate with IT, Quality leaders, and internal stakeholders to implement electronic systems to support the 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) with Quality leads. Establish frameworks and tools to support ongoing inspection readiness. Partner with GMP and GCP Quality leads to establish inspection readiness strategies, planning/preparation, and inspection execution. Provide coordination and project management for inspections and related activities. Ensure global processes, training, and tools remain aligned with regulatory requirements and industry expectations. Define and monitor key quality metrics and trends; establish governance forums to drive continuous improvement. Support management review processes and identification/mitigation of systemic risks. Drive adoption and optimization of eQMS tools 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 QMS, including implementation of electronic systems. Direct experience supporting global regulatory inspections, including pre‑approval inspections. Excellent communication and interpersonal skills across departments and external stakeholders. Detail-oriented, proactive problem-solving and decision-making mindset. Experience 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, execution-focused leadership style. Compensation Range $254K - $295K #J-18808-Ljbffr Scorpion Therapeutics