Senior Quality Systems Engineer/APQR 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 a Senior Quality Systems Engineer/APQR Lead

SUMMARY:

Senior Quality Systems Engineer/APQR 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.

ESSENTIAL FUNCTIONS:

• 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

Requirements

QUALIFICATIONS

Minimum education and years of relevant work experience

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.

Special knowledge or skills needed and/or licenses or certificates required

• 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

Special knowledge or skills needed and/or licenses or certificates preferred

• 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

Travel requirements

• 0%

Physical requirements

• Office / Laboratory based position
• Ability to lift up to 30 lbs
• Ability to use Personal Protective Equipment (PPE)
• Ability to stand for extended periods

Anticipated salary range: $100k – $145k. 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,