Senior Clinical Quality Compliance and Policy Leader

About the role

As a Quality Partner within Early Clinical Development (ECD) Quality, you will champion a proactive, risk-based quality culture that enables innovative science to move safely and efficiently to patients. You will serve as the primary Good Clinical Practice (GCP) quality advisor and strategic partner to early-stage clinical trial study teams and external partners. In this role, you will embed quality by design across cutting-edge Early Development clinical programs, resolving complex compliance challenges before they impact study timelines or regulatory integrity.

Responsibilities

• Develop strategic partnerships with cross-functional teams in Early Clinical Development (ECD) and external vendor partners to advance compliance solutions and enable transparent issue resolution.
• Provide expert GCP quality guidance, direction, and proactive risk-mitigation strategies to support early clinical trial conduct.
• Support and participate in intradepartmental, global, and cross-functional initiatives, working groups, and project teams as a key decision-maker or lead reviewer.
• Support or lead Quality Management System (QMS) activities, including controlled document management, strategic reviews and process alignment.
• Embed quality principles throughout the organization by delivering impactful compliance communications and targeted training to multidisciplinary teams.
• Collaborate on quality compliance checks and desktop assessments to evaluate clinical trial oversight and data integrity.
• Guide clinical study teams through root cause analysis, deviation management, and Corrective Action/Preventative Action (CAPA) plan development.

Requirements

• Bachelor’s degree in a life science, healthcare, or related discipline (advanced degree such as MS, PhD, JD, or MD welcomed).
• 5–8 years of experience in pharmaceutical drug development (or 4–6 years with a Master’s; 3–5 years with a PhD, JD, or MD), with a minimum of 6 years dedicated to a GCP-related discipline or Quality Assurance role.
• Comprehensive working knowledge of Good Clinical Practice (GCP), ICH guidelines, and global regulatory frameworks and how to apply them to clinical trial conduct.
• Proven analytical and problem-solving skills, with a track record of identifying compliance risks, facilitating root cause analyses, and architecting practical CAPA solutions.
• Excel at cross-functional collaboration and stakeholder management, with the ability to translate regulatory requirements into clear, actionable guidance while managing priorities independently.

Qualifications

• Direct experience supporting Early Clinical Development (ECD) or first-in-human (Phase I/Ib) clinical trials.
• Hands-on experience with Health Authority inspection preparedness, sponsor/site inspection hosting, and response strategy development (e.g., FDA, EMA).
• Demonstrated