Annual Product Quality Review Program Lead

About the role

Tris Pharma, Inc. is a leading privately-owned U.S. biopharmaceutical company focused on the development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain, and addiction. 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 statistical trending, data collection, aggregation, and drafting of Annual Product Quality Reviews/Annual Product Reviews (APQRs/APRs) to monitor product/process stability and drive data-driven continuous improvement across production processes in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), FDA standards, and batch record specifications.

Responsibilities

• Maintains all appropriate Quality-related documentation while ensuring adherence to 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 and Subject Matter Experts (SMEs) to submit all sub-reports in a timely, accurate, and compliant manner.
• Hosts APR risk assessment meetings, tracks attendance, and acts on team recommendations.
• Performs advanced trend analysis for intermediate, in-process, finished product, and stability batches, evaluating critical quality attributes (CQAs) and critical process parameters (CPPs) using statistical methods.
• Verifies consistency of existing processes and identifies trends; addresses and reports all negative trends.
• Analyzes and interprets large datasets from Manufacturing, Packaging, Laboratory, complaints, deviations, Corrective Action Preventive Action (CAPAs), change controls, and stability programs to identify statistically significant trends, process shifts, and emerging quality risks.
• 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 the cumulative impact of deviations, CAPAs, change controls, complaints, stability trends, analytical changes, and validation activities on product quality throughout the product lifecycle.
• Recommends revalidation and determines the need for process revalidation or changes to registered specifications based on APQR/APR data.
• Drives root cause investigations by partnering with QA Investigations, Production, Laboratory, and Technical Services teams using tools such as Fishbone, 5 Whys, and Failure Mode and Effects Analysis (FMEA).
• Mitigates specific product risks by addressing unique technical challenges related to company dosage forms and associated intermediates.
• Monitors process capability and calculates/analyzes process indicators such as Process Capability Index (Cpk) and Process Performance Index (Ppk) to monitor process variability.
• Participates in inspections and supports regulatory audits as an SME for APQRs, trending data, and process statistics during FDA and foreign health authority inspections.
• Assists in other areas of QA and cross-trains across the department as needed.

Requirements

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline and a minimum of 5 years of experience in quality systems, process validation, product quality review, or quality engineering in the pharmaceutical or biotechnology industry, or a combination of education and relevant experience 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.
• 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 control charting, process capability analysis, trend analysis, regression analysis, hypothesis testing, ANOVA, sampling plans, and statistical interpretation of manufacturing and laboratory data.
• 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 skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
• Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Strong planning, organization, and time management skills, including the ability to support and prioritize stability programs.
• Fluent in English (verbal and written).
• Ability to identify and distinguish colors.
• Ability and willingness to work additional hours as required by business needs.

Preferred Qualifications

• 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, or Spotfire.

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.

Pay

Anticipated salary range: $100,000 – $145,000. 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.

Benefits

• Bonus eligibility.
• Medical, dental, vision, and prescription insurance.
• 401K with company match.
• Life insurance.
• Paid company holidays and PTO.
• Paid volunteer time.
• Employee Resource Groups.