Director, Clinical Quality Assurance

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.

Our science and technology make us unique, but our team members set us apart; they're the engine fueling Tris' passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company's success. Equally important is how we interact on a daily basis. We believe in each other and in respectful, open and honest communication to help support individual and team success.

We have an immediate opening in Monmouth Junction, NJ for an experienced Director, Clinical Quality Assurance. This is an individual contributor role which may be responsible for leading direct reports in the future.

SUMMARY:

Responsible for establishing, implementing and maintaining the Good Clinical Practice (GCP) Quality Management System to support development of 505(b)(2) drug products. The position ensures all clinical studies, including bioavailability/bioequivalence (BA/BE) studies and clinical trials, are conducted in compliance with applicable regulatory requirements, internal procedures and industry standards.

The role provides GCP oversight for clinical operations, vendors, investigational sites and computerized systems and ensures inspection readiness for FDA and other global health authorities.

ESSENTIAL FUNCTIONS

GCP Quality Management System

• Develop, maintain and continuously improve GCP-related policies, standard operating procedures (SOPs) and controlled documents
• Implement risk-based quality management practices across clinical programs
• Establish and maintain metrics for monitoring clinical quality and compliance

Audit Program and Vendor Oversight

• Develop and execute an annual risk-based GCP audit plan
• Conduct and/or oversee audits of clinical investigator sites, CROs, Phase I units, laboratories (including bioanalytical labs) and eClinical technology vendors
• Document audit observations, assess root cause and oversee corrective and preventive actions (CAPA) through closure and effectiveness verification
• Participate in vendor qualification, assessment and ongoing monitoring
• Contribute to development and maintenance of Quality and Technical Agreements

Clinical Study Oversight

• Provide GCP review and quality input on study-related documents including protocols, Investigator's Brochures, informed consent forms, monitoring plans, data management plans and clinical study reports
• Oversee Trial Master File (TMF) quality and completeness, including periodic review and issue escalation
• Support quality oversight of safety systems, EDC, eCOA and other computerized systems used in clinical research
• Assess and support investigation of deviations, data integrity issues, noncompliance and process gaps

505(b)(2)-Specific Quality Considerations

• Provide quality oversight for BA/BE studies, bridging strategies and studies supporting reformulations, new dosage forms, changes in route of administration or drug-device combination products
• Ensure study designs and execution meet data integrity and regulatory requirements specific to 505(b)(2) submissions
• Support cross-functional teams preparing for regulatory submissions and addressing quality-related inquiries
• Inspection Readiness and Regulatory Interaction; Maintain inspection-ready state for all GCP activities and documentation
• Lead preparation for regulatory inspections, including training, mock interviews and document preparation
• Serve as GCP Quality representative during inspections and manage post-inspection responses and CAPA

Inspection Readiness and Regulatory Interaction

• Maintain inspection-ready state for all GCP activities and documentation
• Lead preparation for regulatory inspections, including training, mock interviews and document preparation
• Serve as GCP Quality representative during inspections and manage post-inspection responses and CAPA

Training and Continuous Improvement

• Provide GCP training to internal staff and external partners, as required
• Support initiatives to improve quality culture and process efficiency
• Oversee external auditors or vendors, as needed

Requirements

QUALIFICATIONS

Minimum education and years of relevant work experience

• Bachelors degree in life sciences (e.g. Biology, Chemistry, Pharmacy) or related field (Advanced degree PREFERRED) AND minimum 8 years experience in Clinical Quality Assurance within the pharmaceutical or biotechnology industry in positions of increasing technical responsibility REQUIRED
• Demonstrated experience with GCP regulations (ICH E6, 21 CFR Parts 11, 50, 54, 56, 312, 314) and global GCP standards REQUIRED
• Experience with audits, vendor oversight and regulatory inspections REQUIRED
• Strong understanding of clinical trial processes and GCP compliance requirements REQUIRED
• Ability to interpret regulations and provide practical quality guidance REQUIRED
• Ability to conduct external audits of investigator sites, CROs, supporting laboratories and monitoring organizations REQUIRED
• Experience in developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in SOPs REQUIRED
• Experience supporting 505(b)(2) development programs or BA/BE studies PREFERRED
• Experience with eClinical systems and Trial Master File management PREFERRED
• Experience with Regulatory approvals (e.g., NDAs and MAAs) PREFERRED

Travel requirements: Position requires periodic domestic and international travel (approx. 20-30% on annual basis).

Work Arrangements: We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Non-local candidates must be able to come into office multiple times a month.

Anticipated salary range: $200 to $ 245K/yr. Base salary offered is contingent on assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

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