Clinical Quality Compliance Lead

Job Title: Clinical Quality Compliance Lead

Location: Cambridge, MA

Position Overview:

We are seeking an experienced Clinical Quality Compliance Lead to provide strategic quality oversight for clinical trial delivery systems. This role is critical in ensuring compliance with GCP regulations and promoting a culture of continuous improvement, operational excellence, and proactive quality risk management. The ideal candidate will be a thought partner to the Head of GCP Quality Compliance and play a key role in developing and executing global GCP compliance strategies.

Key Responsibilities:

• Lead the development and execution of the clinical trial inspection readiness program.
• Partner with cross-functional teams (e.g., Global Development Office, Regulatory Affairs, Legal) to ensure ongoing readiness and regulatory compliance.
• Monitor emerging regulations and provide strategic guidance on inspection preparedness.
• Serve as the lead host during GCP inspections, managing daily communications, risks, and mitigation strategies.
• Oversee the preparation, review, and timely submission of inspection responses.
• Ensure CAPAs are well-documented, aligned with root cause analysis, and implemented effectively.
• Act as a Subject Matter Expert (SME) for clinical quality compliance, covering deviation management, investigations, CAPA oversight, and change control.
• Lead complex investigations and support non-GCP inspections (e.g., GMP, GVP) as needed.
• Develop and maintain quality metrics, KPIs/KQIs, and risk registers to monitor the health of quality systems.
• Drive cross-functional improvement initiatives to strengthen clinical trial quality systems.
• Contribute to quality governance forums and councils, sharing insights, risks, and success stories.
• Promote knowledge sharing and develop lessons learned from inspections and investigations.

Qualifications:

• Bachelor’s degree in a scientific or health-related field (advanced degree preferred).
• Minimum of 7 years’ experience in the global pharmaceutical or biotechnology industry, including at least 3 years in GCP Quality/Compliance.
• Strong background in Clinical Operations, Data Management, or Biostatistics.
• In-depth knowledge of GCP, GVP, and global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH).
• Proven experience in managing regulatory inspections, audit programs, and CAPA implementation globally.
• Skilled in leading global, cross-functional projects and managing complex compliance challenges.