Sr. Director/Executive Director, R&D/Clinical QA

Description

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the US. We also license our products in the US and ex-US markets. Our robust pipeline of innovative products employing our proprietary science and technology spans neuroscience and other therapeutic categories.

We have an opening in our Monmouth Junction facility for an experienced R&D/Clinical Quality leader to oversee our small QA/R&D department. Title commensurate with experience.

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 in support of Research & Development (R&D), Clinical Development, Pharmacovigilance, Medical Affairs, and related regulated activities. The incumbent serves as a senior Quality leader responsible for ensuring compliance with applicable global regulations, industry standards and company policies throughout the product development lifecycle.

She/he partners with R&D, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance and external partners to establish and maintain a robust Quality Management System (QMS) to support 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.   

ESSENTIAL FUNCTIONS 

Strategic Leadership

• 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.

QMS Oversight

• 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.

Clinical Quality Assurance

• Lead GCP Quality Assurance programs supporting global clinical development activities.
• Oversee quality oversight of: Clinical trials, Clinical operations, Site management, CRO activities.
•        Investigator site/CRO audits/Vendor audits/Clinical process audits/System audits.

Research & Nonclinical Quality Oversight

• 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.

Pharmacovigilance and Safety Quality

• 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.

Vendor and Partner Quality Management

• 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.

Risk Management and Data Integrity

• 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.

Leadership and Talent Development

• Build, lead and develop a high-performing R&D and Clinical Quality organization.
• Promote a