Director, Global Clinical Quality & Pharmacovigilance

LB Pharmaceuticals; New York (NY); On-site; USD 200,000 - 215,000; Full time

Job summary

LB Pharmaceuticals seeks a Director of Clinical Quality and Pharmacovigilance to ensure participant safety, data integrity, and global regulatory compliance across clinical development and pharmacovigilance. In a lean biotech environment, you will lead risk-based quality strategy and govern GCP/GVP across sites, CROs, and vendors while supporting regulatory readiness and continuous improvement.

The role requires 10+ years in pharma/biotech with 5+ in quality, strong regulatory knowledge, and

Qualifications

• Bachelor’s degree in a scientific, medical, or related field.
• 10+ years in pharma/biotech with 5+ years in clinical quality/pharmacovigilance.
• Strong knowledge of ICH-GCP, ICH E8, EU GVP, and FDA regulations.
• Experience with audits, inspections, and quality systems.
• Experience overseeing vendor oversight and safety processes.
• Willingness to travel up to 30%.

Responsibilities

• Establish and manage risk-based audit programs across clinical development and pharmacovigilance.
• Develop and maintain quality policies, SOPs, and metrics aligned with ICH and GVP.
• Lead inspection readiness activities for global Health Authorities and coordinate responses.
• Provide quality oversight of regulatory submissions and related processes.

Skills

Audit Program

GCP/GVP

Quality Systems

Regulatory Submissions

Leadership

Training & CAPAs

Education

Bachelor’s degree

Advanced degree preferred

Tools

EDC

eTMF

Safety database

Job description

LB Pharmaceuticals seeks a Director of Clinical Quality and Pharmacovigilance to ensure participant safety, data integrity, and global regulatory compliance across clinical development and pharmacovigilance. In a lean biotech environment, you will lead risk-based quality strategy and govern GCP/GVP across sites, CROs, and vendors while supporting regulatory readiness and continuous improvement.

The role requires 10+ years in pharma/biotech with 5+ in quality, strong regulatory knowledge, and