Director, Clinical Quality Assurance

Tris Pharma Inc•South Brunswick, NJ

2d•$200 - $245•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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
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
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
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
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