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

About the role

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. We have over 150 US and international patents and market several branded ADHD products in the US, as well as license our products domestically and internationally. Our robust pipeline of innovative products employs proprietary science and technology spanning neuroscience and other therapeutic categories.

This role is based at our Monmouth Junction facility and oversees a small QA/R&D department. 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. The incumbent ensures compliance with applicable global regulations, industry standards, and company policies throughout the product development lifecycle.

Responsibilities

• 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 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, and 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, and CRO activities.
  • Conduct Investigator site, CRO, vendor, clinical process, and 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, and 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 culture of accountability, collaboration, transparency, and continuous improvement.

Requirements

• Senior Director
  • Bachelor’s degree in science or related field.
  • Minimum 12 years of quality and/or compliance experience in the pharmaceutical or biotechnology industry, with at least 8 years in Quality Assurance leadership and/or management roles within R&D or Clinical Development.
• Executive Director
  • Bachelor’s degree in science or related field.
  • Minimum 15 years of quality and/or compliance experience in the pharmaceutical or biotechnology industry, with at least 10 years in Quality Assurance leadership and/or management roles within R&D or Clinical Development.
• For Both Roles
  • 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

Schedule

This is a hybrid work environment requiring local candidates to work the majority of the week in our New Jersey office.

Pay

• Senior Director: $235,000 to $255,000 per year. Base salary is contingent on assessment of candidate’s education and experience level relative to the requirements of the position and a review of related industry standards and internal equity.
• Executive Director: $250,000 to $275,000 per year. Base salary is contingent on assessment of candidate’s education and experience level relative to the requirements of the position and a review of related industry standards and internal equity.

Benefits

• Bonus eligibility
• Medical, dental, and vision insurance
• Prescription insurance
• 401K with company match
• Life insurance
• Paid company holidays
• Paid time off (PTO)
• Paid volunteer time
• Employee Resource Groups