APQR Program Lead: Quality Analytics & Process Improvement

BioSpace; South Brunswick (NJ); On-site; USD 100,000 - 145,000; Full time

Benefits offered by this job

Bonus eligible

Medical, dental, vision insurance

401K with match

Paid holidays

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ, is seeking an Annual Product Quality Review (APQR) Program Lead to oversee data-driven quality reviews and trend analysis for FDA-compliant manufacturing.

You will lead cross-functional teams to assess CQAs, CPPs and CAPAs, and drive continuous improvement across production processes. The role requires a strong background in statistics, process validation, and GMP practices, with proficiency in Minitab, SAS and data visualization tools.

Qualifications

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry or related field.
• Minimum 5 years in quality systems, process validation, or product quality review in pharma/biotech.

Responsibilities

• Maintain quality documentation in compliance with SOPs and cGMPs.
• Lead evaluation of annual product quality data to identify risks and opportunities for improvement.
• Perform advanced trend analysis and report negative trends.
• Support inspections and act as SME for APQRs and statistics.

Skills

FDA regulations

Statistical analysis

Minitab

JMP

SAS

Microsoft Office

English proficiency

Root cause analysis

Process validation

Color vision

Education

Bachelor's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry

Tools

Power BI

Tableau

JMP Live

Spotfire

Job description

Tris Pharma, Inc. in Monmouth Junction, NJ, is seeking an Annual Product Quality Review (APQR) Program Lead to oversee data-driven quality reviews and trend analysis for FDA-compliant manufacturing.

You will lead cross-functional teams to assess CQAs, CPPs and CAPAs, and drive continuous improvement across production processes. The role requires a strong background in statistics, process validation, and GMP practices, with proficiency in Minitab, SAS and data visualization tools.