Senior Manager/Manager, Quality Management Systems

Company: Tris Pharma
Location: Monmouth Junction
Posted on: June 28, 2025

Job Description:

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus 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 U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are 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 importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience. Summary: This position supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. The incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality functions and systems including, but not limited to: investigations, deviations, Out-of-Specifications (OOS)/Out-of-Trend (OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities: Assures compliance with all SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objective Oversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab Event, Product Quality Complaints (PQCs), Corrective Action Preventive Actions (CAPAs) and Continuous Process Improvements (CPIs) Works directly and cross functionally throughout company (i.e., QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and overseeing and ensuring timely, accurate, effective and compliant investigation and resolution Reviews and approves laboratory (OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriate Applies quality risk management principles in design (and resolution) of key quality management system elements to ensure compliance Tracks and trends deviations and product quality complaints Engages in activities to continuously assess/improve quality systems by identifying and proactively resolving quality issues Develops, analyzes and compiles quality metrics and highlights; Reports periodic quality metrics pertaining to investigations/CAPAs/CPIs and PQCs to Quality leadership and other appropriate company personnel Assists in training, including but not limited to: investigative processes, CAPAs and CPIs, etc. Participates in regulatory agency inspections and customer audits, as needed; Performs and/or participates in internal and external audits, as needed Manages, coaches and mentors direct reports Any other assignments determined by Quality management Requirements Minimum education and years of relevant work experience: Bachelors degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 3 of those years in a supervisory or manager role) Special knowledge or skills needed and/or licenses or certificates required People management experience Strong hands-on knowledge of cGMPs in the pharmaceutical industry and application of current Good Documentation Practices (cGDPs) within pharmaceutical industry Experience implementing and managing quality systems and processes Familiar with US FDA guidance and other international guidelines on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Strong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective investigations Proficiency with Microsoft Office Special knowledge or skills needed and/or licenses or certificates preferred Certified Quality Manager, Engineer or Auditor Experience working with drug-device combination products (highly desirable) Work Arrangements: 100% in office. Anticipated salary range: $120-160k/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 package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans and women, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. LI-DNI

Keywords: Tris Pharma, Milford , Senior Manager/Manager, Quality Management Systems, Science, Research & Development , Monmouth Junction, Connecticut