Clinical QA

Tris Pharma•Monmouth Junction, NJ

6d•Hybrid

About The Position

Tris Pharma, Inc. is a leading privately-owned US biopharmaceutical company focused on the development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain, and addiction, addressing unmet patient needs. With over 150 US and International patents, the company markets several branded ADHD products in the US and licenses its products domestically and internationally. Tris Pharma has a robust pipeline of innovative products employing proprietary science and technology across neuroscience and other therapeutic categories. This role oversees a small QA/R&D department at the Monmouth Junction facility, with the title commensurate with experience. The Senior or Executive Director, Research and Development Quality Assurance (R&D QA) provides strategic leadership and oversight of assigned R&D/QA and GxP Compliance programs supporting Research & Development (R&D), Clinical Development, Pharmacovigilance, Medical Affairs, and related regulated activities. This senior Quality leader ensures compliance with global regulations, industry standards, and company policies throughout the product development lifecycle. The role partners with R&D, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and external partners to establish and maintain a robust Quality Management System (QMS) supporting patient safety, data integrity, product quality, and regulatory compliance. The incumbent also drives inspection readiness, risk management, quality culture, continuous improvement, and organizational excellence across global development programs.

Requirements

SR DIRECTOR: 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).
EXECUTIVE 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).
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)
Demonstrated expertise in: Good Pharmacovigilance Practice (GVP)
Demonstrated expertise in: Good Laboratory Practice (GLP)
Demonstrated expertise in: ICH E6 (R3), E8, E9, E17
Demonstrated expertise in: ICH Q9 and Q10
Demonstrated expertise in: FDA regulations
Demonstrated expertise in: EU Clinical Trial Regulations
Demonstrated expertise in: Data Integrity and ALCOA+ principles
Demonstrated expertise in: Risk-based quality management
Demonstrated expertise in: 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 the 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.
Conduct 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.