R&D Quality & Compliance Leader

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

Benefits offered by this job

Bonus eligible

Medical insurance

Dental plan

Vision plan

401K with match

Life insurance

Paid holidays

PTO

Volunteer time

Employee Resource Groups

Job summary

Tris Pharma, Inc. seeks an experienced Senior/Executive Director, R&D Quality Assurance to lead the QA/Compliance program across research and development, clinical development, pharmacovigilance and medical affairs.

The role chairs the global QMS, drives inspection readiness, data integrity, and supplier quality, partnering with cross-functional teams to ensure patient safety and product quality. You will establish quality governance, oversee audits, and mentor a high-performing QA organization

Qualifications

• Minimum 12 years quality/compliance in pharmaceutical/biotechnology with 8+ in QA leadership within R&D or Clinical Development.
• Executive Director requires 15 years quality/compliance with 10+ in QA leadership within R&D or Clinical Development.

Responsibilities

• Develop global R&D Quality Assurance and Compliance strategy aligned with corporate objectives.
• Provide quality oversight for research, nonclinical and clinical development, pharmacovigilance and medical affairs activities.
• Lead GxP compliance programs and CRO/CMO/vendor quality oversight.
• Drive inspection readiness, risk management and quality culture across development programs.
• Oversee audits of clinical trials, nonclinical studies and development partners.
• Establish and maintain a robust Quality Management System (QMS) for patient safety and data integrity.

Skills

Quality leadership

Regulatory compliance

GxP systems

Vendor management

Risk management

Data integrity

Audit readiness

Strategic planning

Team development

Education

Bachelor's degree in science

Job description

Tris Pharma, Inc. seeks an experienced Senior/Executive Director, R&D Quality Assurance to lead the QA/Compliance program across research and development, clinical development, pharmacovigilance and medical affairs.

The role chairs the global QMS, drives inspection readiness, data integrity, and supplier quality, partnering with cross-functional teams to ensure patient safety and product quality. You will establish quality governance, oversee audits, and mentor a high-performing QA organization