Principal Quality Compliance and Policy Leader

• Drive strategic partnerships across Early Clinical Development (ECD) and global cross-functional stakeholders to align compliance strategy and address high-complexity quality matters.
• Provide strategic quality direction, Good Clinical Practice (GCP) compliance expertise, and proactive risk-mitigation frameworks for early clinical study programs.
• Lead high-impact global initiatives, working groups, and compliance policy development as a key decision-maker and strategic reviewer.
• Oversee Quality Management System (QMS) activities, including deviation management, robust root cause analysis, and strategic Corrective Action/Preventive Action (CAPA) evaluations.
• Direct Health Authority inspection readiness initiatives, Standard Operating Procedure (SOP) optimizations, and strategic response frameworks for global regulatory inspections.
• Establish Key Quality Indicators (KQIs) and compliance metrics to proactively identify systemic trends, mitigate study risks, and drive continuous organizational improvement.
• Champion a robust culture of quality across early development programs through targeted training and strategic compliance communications.
• Manage and lead a team through hiring, strategic direction, oversight, ongoing coaching, regular communication, and performance development.

Who you are

• Education & Foundation: You bring a Bachelor’s degree in life sciences or a related healthcare discipline.
• Industry Experience: You bring a minimum of 7–12 years of progressive experience in pharmaceutical drug development (or 6–8 years with a Master’s; 5–7 years with a PhD, JD, or MD), with focused experience in regulatory compliance or clinical quality assurance.
• GCP & Regulatory Mastery: You possess a minimum of 8 years in a GCP-related discipline or clinical quality assurance role, demonstrating expert-level knowledge of GCP/ICH guidelines, global health authority regulations (e.g., FDA, EMA), and clinical trial best practices.
• Strategic Problem Solver & Matrix Leader: You have a proven track record of strategic problem-solving, matrix leadership, and leading continuous process improvements in complex, fast-paced clinical environments.
• Influential Communicator: You excel at stakeholder management, executive influence, and distilling intricate compliance regulations into clear, actionable clinical strategies.

Preferred

• Advanced degree (Master’s, PharmD, PhD, or JD) in a scientific, medical, or regulatory discipline.
• Direct prior experience supporting Early Clinical Development (Phase 0–IIa/b) and translational research quality assurance.
• Proven leadership experience managing or mentoring quality compliance professionals, working groups, or direct reports.
• Hands-on experience hosting and leading Health Authority inspections (e.g., FDA, EMA, PMDA) and authoring formal regulatory responses.
• Expertise in developing and scaling QMS architectures, quality metrics, and risk-based quality management (RBQM) platforms.