We’re partnering with an innovative biopharmaceutical organization with a broad pipeline that is seeking a Senior Manager, Clinical Quality Assurance (CQA) to lead GCP quality activities across a diverse portfolio of clinical development programs. This is a high-impact opportunity for a quality professional who thrives in a collaborative, science-driven environment and enjoys influencing quality strategy across global clinical operations.

What You’ll Do

• Lead and conduct GCP audits including investigator sites, vendors/CROs, and internal processes
• Develop and execute risk-based audit strategies and study-specific audit plans
• Serve as the primary Clinical Quality Assurance Lead for assigned development programs
• Partner with clinical teams to identify compliance risks and implement mitigation strategies
• Support regulatory inspection readiness activities and assist with inspection response planning
• Provide guidance on CAPAs, remediation plans, and continuous quality improvement initiatives
• Monitor quality metrics, perform trend analyses, and present findings to leadership
• Contribute to the development and enhancement of SOPs, quality systems, and training programs
• Mentor cross-functional teams on GCP requirements and industry best practices

What We’re Looking For

• Bachelor’s or Master’s degree in Life Sciences, Nursing, or a related scientific discipline
• 6-8+ years of pharmaceutical, biotech, or clinical research experience, including significant Clinical Quality Assurance experience supporting drug development programs
• Deep knowledge of:
  • GCP regulations and ICH guidelines
  • FDA and global clinical trial requirements
  • Clinical investigator site and vendor auditing
  • CAPA management and inspection readiness
• Experience supporting Phase I-IV clinical studies
• Strong project management, communication, and stakeholder management skills
• Ability to influence cross-functional teams and drive quality culture across the organization

Preferred Experience

• Gene therapy, advanced therapies, or complex clinical development programs
• Building and managing comprehensive GCP audit programs
• Leading investigator site, CRO, and vendor audits globally
• Regulatory inspection support and health authority interactions

Why This Opportunity?

• Strategic, highly visible quality leadership role
• Broad exposure across multiple therapeutic areas and clinical programs
• Opportunity to shape quality systems and drive continuous improvement initiatives
• Collaborative and mission-driven culture focused on advancing treatments for patients with significant unmet needs