Global R&D QA & Compliance Director

Tris Pharma; South Brunswick (NJ); Hybrid; USD 235,000 - 275,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Rx insurance

401K with match

Life insurance

Paid company holidays

PTO

Volunteer time off

Employee resource groups

Job summary

Tris Pharma, Inc. in New Jersey seeks an experienced R&D Quality Assurance leader to oversee a small QA/R&D unit. The role provides strategic guidance on GxP compliance for clinical and nonclinical programs, pharmacovigilance and medical affairs, with partnerships across R&D and Regulatory groups.

The incumbent leads QA governance, inspection readiness and data integrity initiatives to ensure patient safety and regulatory compliance throughout development lifecycles.

Qualifications

• Significant experience leading global R&D/Clinical QA and GxP compliance programs.
• Experience interacting with FDA, EMA, MHRA and other agencies is REQUIRED.
• Proven track record building high-performing QA organizations in pharma/biotech.

Responsibilities

• Provide strategic leadership for R&D QA and compliance across clinical, nonclinical and pharmacovigilance activities.
• Oversee audits, inspections, CAPAs, vendor quality and GxP governance.
• Drive data integrity, risk management and continuous improvement across development programs.

Skills

GxP compliance

Regulatory inspections

Quality leadership

Clinical QA

GCP/GVP/GLP

Education

Bachelors in science or related field

Job description

Tris Pharma, Inc. in New Jersey seeks an experienced R&D Quality Assurance leader to oversee a small QA/R&D unit. The role provides strategic guidance on GxP compliance for clinical and nonclinical programs, pharmacovigilance and medical affairs, with partnerships across R&D and Regulatory groups.

The incumbent leads QA governance, inspection readiness and data integrity initiatives to ensure patient safety and regulatory compliance throughout development lifecycles.