Annual Product Quality Review Program Lead

Summary

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. The role 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 continuous improvement across various production processes in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), FDA standards and batch record specifications.

• Maintains all appropriate quality related documentation, ensuring adherence to company policies, SOPs and cGMPs.
• Leads evaluation of annual product quality data to identify emerging risks, process variability, and opportunities for improvement; applies statistical methods and quality risk management principles to transform data into actionable decisions.
• Hosts APR risk assessment meetings, tracks attendance and follows up on team recommendations.
• Performs advanced trend analysis for intermediate, in‑process, finished product and stability batches; evaluates critical quality attributes and process parameters using statistical tools, identifies and reports negative trends.
• Analyzes and interprets large datasets from manufacturing, packaging, lab, complaints, deviations, CAPAs, change controls and stability programs to identify statistically significant trends, process shifts and emerging quality risks.
• Applies statistical methods including control charts, capability analysis, regression, Pareto analysis and trend modeling to evaluate process performance and product lifecycle health.
• Assesses cumulative impact of deviations, CAPAs, change controls, complaints, stability trends, analytical changes and validation activities on product quality throughout the product lifecycle.
• Recommends revalidation or changes to specifications based on APQR/APR data.
• Drives root cause investigations by partnering with QA, production, laboratory and technical services teams, using Fishbone, 5 Whys and FMEA tools to mitigate product risks.
• Monitors process capability and calculates process indicators such as Cpk and Ppk to assess variability.
• Participates in inspections and supports regulatory audits as SME for APQRs, trending data and process statistics during FDA and foreign inspections; assists in other QA areas and may cross‑train as needed.
• Completes any other APR tasks assigned by supervisor or senior management.

Minimum Education:

Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or related scientific discipline. Minimum 5 years of quality systems, process validation, product quality review or quality engineering experience in the pharmaceutical or biotechnology industry, or equivalent combination of education and experience.

• Deep understanding of FDA 21 CFR Part 210/211, ICH Q8, Q9, and Q10.
• Familiarity with laboratory testing equipment such as automated dissolution testers, HPLC, particle size analyzers and viscometers.
• Ability to translate statistical observations into quality risk assessments and business recommendations.
• Proficiency in statistical platforms such as Minitab, JMP or SAS for process trending and control charting.
• Experience applying statistical methodologies including control charting, capability analysis, trend analysis, regression, hypothesis testing, ANOVA, sampling plans and interpretation of manufacturing and laboratory data.
• Strong foundational knowledge of Process Validation lifecycle stages and experience developing, monitoring, and interpreting CPV data.
• ASQ Certification: CQE or CQA.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively within a matrixed, fast‑paced team environment.
• Analytical thinking, problem‑solving skills and adaptability to changing priorities and deadlines.
• Strong planning, organization and time‑management skills.
• Fluent in English (verbal and written).
• Ability to identify and…