Clinical QA

Tris Pharma Inc•South Brunswick, NJ

7d•$235,000 - $275,000•Hybrid

About The Position

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on the development and commercialization of innovative medicines. They have an opening for an experienced R&D/Clinical Quality leader to oversee their small QA/R&D department. The Senior or Executive Director, Research and Development Quality Assurance (R&D QA) is responsible for providing strategic leadership and oversight of assigned R&D/QA and GxP Compliance programs. This role supports Research & Development (R&D), Clinical Development, Pharmacovigilance, Medical Affairs, and related regulated activities, ensuring compliance with global regulations, industry standards, and company policies throughout the product development lifecycle. The incumbent partners with various departments and external partners to maintain a robust Quality Management System (QMS) supporting patient safety, data integrity, product quality, and regulatory compliance. This role also drives inspection readiness, risk management, quality culture, continuous improvement, and organizational excellence.

Requirements

Bachelors degree in science or related field and minimum 12 years quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 8 of those years in roles with Quality Assurance leadership and/or management responsibility within R&D or Clinical Development) for Sr. Director.
Bachelors degree in science or related field and minimum 15 years quality and/or compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 10 of those years in roles with Quality Assurance leadership and/or management responsibility within R&D or Clinical Development) for Executive Director.
Significant experience supporting global development programs and regulatory inspections.
Demonstrated experience managing Clinical Quality Assurance (CQA) and GxP compliance programs.
Proven experience leading global audit and inspection readiness programs.
Experience interacting directly with FDA, EMA, MHRA, PMDA and other regulatory agencies.
Experience managing and developing high-performing Quality organizations.
Demonstrated expertise in: Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), ICH E6 (R3), E8, E9, E17, ICH Q9 and Q10, FDA regulations, EU Clinical Trial Regulations, Data Integrity and ALCOA+ principles, Risk-based quality management, Clinical trial systems and technologies.

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.
Serve as a strategic business partner to executive leadership and development teams.
Lead quality governance programs and participate in executive quality review forums.
Establish, maintain and continually improve R&D Quality Management System ensuring compliance with FDA regulations, ICH Guidelines (E6, E8, E9, E17, Q9, Q10), EU Clinical Trial Regulation, EMA, MHRA, PMDA and Global GCP, GVP, GLP, and applicable GxP regulations.
Oversee Quality management including: SOPs, Deviations, CAPA systems, Change control, Vendor quality management.
Lead GCP Quality Assurance programs supporting global clinical development activities.
Oversee quality oversight of: Clinical trials, Clinical operations, Site management, CRO activities.
Oversee Investigator site/CRO audits/Vendor audits/Clinical process audits/System audits.
Provide quality oversight for research and nonclinical development activities.
Support compliance with applicable GLP and research quality requirements.
Oversee audits of: Nonclinical laboratories, Research organizations, Contract testing facilities and Development partners.
Ensure appropriate quality and compliance controls are integrated into development programs.
Provide quality oversight of Pharmacovigilance and Drug Safety systems.
Ensure compliance with global GVP requirements.
Oversee: Safety-related audits, Vendor oversight, Safety governance processes, Inspection readiness activities.
Partner with Safety leadership to ensure robust adverse event reporting processes and patient safety protection.
Develop risk-based oversight programs for CROs, CMOs, laboratories, consultants and development partners.
Lead qualification, audit and performance monitoring programs.
Ensure quality agreements are established and maintained.
Evaluate vendor compliance risks and implement appropriate mitigation strategies.
Ensure implementation of Quality Risk Management principles consistent with ICH Q9.
Drive proactive risk assessments across development programs.
Establish and maintain robust data integrity programs consistent with ALCOA++ principles.
Monitor emerging compliance risks and implement appropriate action plans.
Build, lead and develop a high-performing R&D and Clinical Quality organization.
Promote a culture of accountability, collaboration, transparency and continuous improvement.