Manager, Clinical Quality Assurance

DescriptionTris 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 Manager, Clinical Quality Assurance.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 FunctionsGCP Quality Management SystemDevelop, maintain and continuously improve GCP-related policies, standard operating procedures (SOPs) and controlled documentsImplement risk-based quality management practices across clinical programsEstablish and maintain metrics for monitoring clinical quality and complianceAudit Program and Vendor OversightDevelop and execute an annual risk-based GCP audit planConduct and/or oversee audits of clinical investigator sites, CROs, Phase I units, laboratories (including bioanalytical labs) and eClinical technology vendorsDocument audit observations, assess root cause and oversee corrective and preventive actions (CAPA) through closure and effectiveness verificationParticipate in vendor qualification, assessment and ongoing monitoringContribute to development and maintenance of Quality and Technical AgreementsClinical Study OversightProvide 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 reportsOversee Trial Master File (TMF) quality and completeness, including periodic review and issue escalationSupport quality oversight of safety systems, EDC, eCOA and other computerized systems used in clinical researchAssess and support investigation of deviations, data integrity issues, noncompliance and process gaps505(b)(2)-Specific Quality ConsiderationsProvide quality oversight for BA/BE studies, bridging strategies and studies supporting reformulations, new dosage forms, changes in route of administration or drug–device combination productsEnsure study designs and execution meet data integrity and regulatory requirements specific to 505(b)(2) submissionsSupport cross-functional teams preparing for regulatory submissions and addressing quality-related inquiriesInspection Readiness and Regulatory InteractionMaintain inspection-ready state for all GCP activities and documentationParticipate in preparation for regulatory inspections, including training, mock interviews and document preparationServe as GCP Quality representative during inspections and manage post-inspection responses and CAPATraining and Continuous ImprovementProvide GCP training to internal staff and external partners, as requiredSupport initiatives to improve quality culture and process efficiencyRequirementsQUALIFICATIONSMinimum Education And Years Of Relevant Work ExperienceBachelors degree in life sciences (e.g. Biology, Chemistry, Pharmacy) or related field AND minimum 6 years experience in Clinical Quality Assurance within the pharmaceutical or biotechnology industry REQUIRED Demonstrated experience with GCP regulations (ICH E6, 21 CFR Parts 11, 50, 54, 56, 312, 314) and global GCP standards REQUIREDExperience with audits, vendor oversight and regulatory inspections required REQUIREDStrong understanding of clinical trial processes and GCP compliance requirements REQUIREDAbility to interpret regulations and provide practical quality guidance REQUIREDAbility to conduct external audits of investigator sites, CROs, supporting laboratories and monitoring organizations REQUIREDExperience in developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in SOPs REQUIREDTravel requirements: Position requires periodic domestic and international travel (approx. 20–30% on annual basis).Work Arrangements: We are a HYBRID work environment requiring candidates to be able to work majority of week in our NJ office.Anticipated salary range: $135 to $175K/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.