Global R&D QA Executive Director - Compliance & Audit

Tris Pharma, Inc.; New Jersey; Hybrid; USD 235,000 - 275,000; Full time

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks an experienced Senior/Executive Director, R&D Quality Assurance to lead the small QA/R&D unit.

You will shape strategies to ensure global GxP compliance across research, nonclinical and clinical development. This hybrid role requires partnering with regulatory and development teams, driving inspections readiness, data integrity, and continuous improvement while building a high-performing QA organization.

Qualifications

• Extensive experience in quality and compliance within pharma/biotech.
• Experience with GxP, FDA, EMA, MHRA, PMDA inspections.
• Proven leadership of global audit and inspection readiness programs.
• Expertise in GCP, GVP, GLP, and data integrity.

Responsibilities

• Develop and execute global R&D QA strategy aligned with corporate objectives.
• Provide quality oversight for research, nonclinical, clinical development, pharmacovigilance, and medical affairs.
• Lead QMS governance and maintain SOPs, CAPA, change control.
• Oversee audits: Investigator site/CRO/vendor.
• Ensure regulatory inspection readiness and risk management.

Skills

Quality Assurance leadership

Regulatory inspections

GxP compliance

Quality governance

Risk management

Data integrity

Leadership and talent development

Regulatory agency interaction

Education

Bachelors degree in science or related field

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ, seeks an experienced Senior/Executive Director, R&D Quality Assurance to lead the small QA/R&D unit.

You will shape strategies to ensure global GxP compliance across research, nonclinical and clinical development. This hybrid role requires partnering with regulatory and development teams, driving inspections readiness, data integrity, and continuous improvement while building a high-performing QA organization.