R&D QA Director — Global Compliance & Audit

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

Benefits offered by this job

Hybrid work

Competitive pay

Incentive program

Job summary

Tris Pharma, Inc. is seeking an experienced Senior/Executive Director of R&D Quality Assurance to lead global QA/Compliance programs across R&D, Clinical, and Pharmacovigilance. The role demands strategic leadership, regulatory liaison with FDA/EMA, and building a robust QMS.

Hybrid work arrangement in New Jersey is required. The position offers a competitive compensation package with incentive opportunities and strong emphasis on patient safety and data integrity.

Qualifications

• Bachelor's degree in science with 12+ years quality/compliance experience, including 8+ years in QA leadership.
• Executive Director requires 15+ years QA/compliance with 10+ years in leadership roles.
• Experience supporting global development programs and regulatory inspections is REQUIRED.
• Proven expertise in GCP, GVP, GLP, ICH guidelines and FDA/EMA regulations.

Responsibilities

• Develop and execute global R&D Quality Assurance and Compliance strategy aligned with corporate objectives.
• Provide quality oversight for research, nonclinical, clinical development, pharmacovigilance, and medical affairs activities.
• Lead quality governance programs and participate in executive quality review forums.
• Oversee audits of CROs, CMOs, laboratories and development partners to ensure GxP compliance.
• Drive inspection readiness and data integrity across development programs.

Skills

Quality leadership

GxP compliance

Regulatory inspections

Clinical QA

FDA/EMA interactions

Education

Bachelor's degree in science

Job description

Tris Pharma, Inc. is seeking an experienced Senior/Executive Director of R&D Quality Assurance to lead global QA/Compliance programs across R&D, Clinical, and Pharmacovigilance. The role demands strategic leadership, regulatory liaison with FDA/EMA, and building a robust QMS.

Hybrid work arrangement in New Jersey is required. The position offers a competitive compensation package with incentive opportunities and strong emphasis on patient safety and data integrity.