Annual Product Quality Review Program Lead

Tris Pharma Inc•South Brunswick, NJ

1d•$100,000 - $145,000•Onsite

About The Position

Tris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on developing and commercializing innovative medicines. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for an Annual Product Quality Review (APQR) Program Lead. The 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.

Requirements

Bachelors degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline and minimum 5 years in quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility OR combination of education and related quality systems, process validation, product quality review or quality engineering in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility.
Deep understanding of FDA 21 CFR Part 210/211, ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10
Familiarity with laboratory testing equipment such as automated dissolution testers, High Pressure Liquid Chromatography (HPLC), particle size analyzers and viscometers/rheometers, etc.
Ability to translate statistical observations into quality risk assessments and business recommendations using risk management tools and structured decision-making methodologies
Proficiency in statistical analysis platforms such as Minitab, JMP or SAS for process trending and control charting
Demonstrated experience applying statistical methodologies including, but not limited to: Control charting, Process capability analysis, Trend analysis, Regression analysis, Hypothesis testing, Analysis of Variance (ANOVA), Sampling plans, Statistical interpretation of manufacturing and laboratory data, etc.
Validation Knowledge: Strong foundational knowledge of Process Validation lifecycle stages (Stage 1, 2, and Stage 3 Continued Process Verification). Experience developing, monitoring, and interpreting Continued Process Verification (CPV) data and process performance indicators
ASQ Certification: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
Proficiency with Microsoft Office
Excellent verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize stability program
Fluent in English (verbal and written)
Ability to identify and distinguish colors
Ability and willingness to work additional hours as required by business needs

Nice To Haves

Experience working with various dosage manufacturing (oral solid or liquid dosages, delayed or extended release products, etc.)
Lean Six Sigma: Green Belt or Black Belt certification
Experience with data visualization and reporting tools such as Power BI, Tableau, JMP Live, Spotfire, or equivalent platforms

Responsibilities

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 Root Cause Investigations by partnering with QA Investigations, Production, Laboratory, and Technical Services teams to investigate deviations using appropriate tools (i.e., Fishbone, 5 Whys and Failure Mode and Effects Analysis (FMEA)); Mitigates specific product risks by addressing unique technical challenges to company dosage forms and its associated intermediates
Monitors process capability and calculates and analyzes process indicators such as Process Capability Index (Cpk) and Process Capability Index (Ppk) to monitor process variability
Maintains all appropriate Quality related documentation, as assigned, while assuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs pertaining to documentation and records management
Participates in inspections, as needed and supports Regulatory audits by acting as SME for APQRs, trending data and process statistics during FDA and foreign health authority inspections; Assists in other areas of QA and may cross train across department, as needed
Any other APR tasks assigned by Supervisor or Quality Senior Management