Annual Product Quality Review Program Lead

Description

Tris Pharma, Inc. () 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 an Annual Product Quality Review (APQR) Program Lead

The Annual Product Quality Review (APQR) Program Lead supports and assists the Quality Assurance (QA) function by merging product data evaluation under FDA 21 CFR 211.180(e) with technical engineering controls to ensure commercial products consistently meet safety, identity, strength, quality and purity standards. The incumbent leads the statistical trending, data collection and aggregation and drafting of Annual Product Quality Reviews /Annual Product Reviews (APQRs/APRs) to monitor product/process stability and make data-driven continuous improvement across various production processes in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.

• Maintains all appropriate Quality related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs
• Leads the evaluation of annual product quality data to identify emerging quality risks, process variability, adverse trends and opportunities for continuous improvement;
  Utilizes statistical methods and quality risk management principles to transform manufacturing, laboratory and stability data into actionable business and compliance decisions;
  Collaborates with various departments, functions and appropriate Subject Matter Experts (SMEs) to submit all sub-reports in a timely, accurate and complaint manner
• Hosts APR risk assessment meeting, tracks attendance and takes appropriate actions on team recommendations
• Performs Advanced Trend Analysis for Intermediate, In-process, Finished Product and Stability batches:
  Evaluates critical quality attributes (CQAs) and critical process parameters (CPPs) using statistical methods;
  Verifies consistency of existing processes and identifies trends;
  Properly addresses and reports all negative trends
• Analyzes and interprets large datasets from Manufacturing, Packaging, Laboratory departments, complaints, deviations, Corrective Action Preventive Action (CAPAs), change controls and stability programs to identify statistically significant trends, process shifts and emerging quality risks including, but not limited to: analyzing Deviation and Rejection Profiles, trending manufacturing deviations, batch failures, yield losses and Out-of-Specification (OOS) laboratory findings (i.e., dissolution, uniformity, particle size), etc.
• Applies statistical methods including control charts, process capability analysis, regression analysis, Pareto analysis and trend modeling to evaluate process performance and product lifecycle health
• Evaluates cumulative impact of deviations, CAPAs, change controls, complaints, stability trends, analytical changes and validation activities on product quality throughout product lifecycle
• Recommends revalidation and determines the need for process revalidation or changes to registered specifications based on APQR/APR data and conclusion
• Drives…