Senior Quality Systems Engineer/APQR Lead

Tris Pharma•Monmouth Junction, NJ

1d•Onsite

About The Position

The Senior Quality Systems Engineer/APQR Lead supports the Quality Assurance function by combining product data evaluation under FDA 21 CFR 211.180(e) with technical engineering controls to help ensure commercial products consistently meet safety, identity, strength, quality, and purity standards. The role leads statistical trending, data collection and aggregation, and drafting of Annual Product Quality Reviews/Annual Product Reviews (APQRs/APRs), monitoring product and process stability and supporting data-driven continuous improvement in accordance with SOPs, cGMPs, FDA standards, and batch record specifications. The position evaluates annual product quality data and large datasets from manufacturing, packaging, laboratory, complaints, deviations, CAPAs, change controls, and stability programs. It uses statistical methods and quality risk management to identify emerging risks, process variability, adverse trends, process shifts, and improvement opportunities. The role assesses critical quality attributes and critical process parameters, process capability, and the cumulative impact of quality events and lifecycle activities; it also recommends revalidation or changes to registered specifications based on APQR/APR findings. The APQR Lead collaborates with Quality Assurance, Production, Laboratory, Technical Services, other departments, and subject matter experts. It hosts APR risk assessment meetings, supports root-cause investigations, maintains quality documentation, and serves as an APQR and statistical-trending subject matter expert during regulatory inspections and audits. The position may also assist with other QA activities and cross-train as needed.

Requirements

Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline, with at least 5 years of relevant experience in quality systems, process validation, product quality review, or quality engineering in the pharmaceutical or biotechnology industry, in positions of increasing technical responsibility; or an equivalent combination of education and relevant experience.
Deep understanding of FDA 21 CFR Parts 210/211 and ICH Q8, ICH Q9, and ICH Q10.
Familiarity with laboratory testing equipment such as automated dissolution testers, 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 with statistical analysis platforms such as Minitab, JMP, or SAS for process trending and control charting.
Demonstrated experience with 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 the Process Validation lifecycle stages (Stages 1, 2, and 3 Continued Process Verification).
Experience developing, monitoring, and interpreting Continued Process Verification (CPV) data and process performance indicators.
ASQ 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 environment with internal and external team members.
Analytical thinking, excellent problem-solving skills, and ability to adapt to changing priorities and deadlines.
Excellent planning, organization, and time-management skills, including the ability to support and prioritize the stability program.
Fluency in English, verbal and written.
Ability to identify and distinguish colors.
Ability and willingness to work additional hours as required by business needs.
Ability to lift up to 30 lbs, use PPE, and stand for extended periods.

Nice To Haves

Experience with various dosage manufacturing, including oral solid or liquid dosages and delayed- or extended-release products.
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

Maintain assigned quality documentation and ensure compliance with company quality policies, practices, SOPs, cGMPs, and documentation and records-management requirements.
Lead evaluation of annual product quality data to identify emerging quality risks, process variability, adverse trends, and opportunities for continuous improvement.
Use statistical methods and quality risk management principles to turn manufacturing, laboratory, and stability data into actionable business and compliance decisions.
Coordinate with departments, functions, and subject matter experts to obtain and submit sub-reports accurately and on time.
Host APR risk assessment meetings, track attendance, and take appropriate actions on team recommendations.
Perform advanced trend analysis for intermediate, in-process, finished-product, and stability batches.
Evaluate critical quality attributes and critical process parameters using statistical methods; verify process consistency, identify trends, and appropriately address and report negative trends.
Analyze and interpret datasets from manufacturing, packaging, laboratory, complaints, deviations, CAPAs, change controls, and stability programs to identify significant trends, process shifts, and emerging quality risks.
Analyze deviation and rejection profiles, manufacturing deviations, batch failures, yield losses, and out-of-specification laboratory findings, including dissolution, uniformity, and particle-size results.
Apply control charts, process capability analysis, regression analysis, Pareto analysis, and trend modeling to evaluate process performance and product lifecycle health.
Evaluate the cumulative impact of deviations, CAPAs, change controls, complaints, stability trends, analytical changes, and validation activities on product quality throughout the product lifecycle.
Recommend revalidation and determine whether process revalidation or changes to registered specifications are needed based on APQR/APR data and conclusions.
Drive root-cause investigations with QA Investigations, Production, Laboratory, and Technical Services teams using appropriate investigation tools.
Address product-specific technical risks related to company dosage forms and associated intermediates.
Monitor process capability and calculate and analyze process indicators such as Cpk and Ppk.
Participate in inspections as needed and support regulatory audits by serving as an SME for APQRs, trending data, and process statistics during FDA and foreign health authority inspections.
Assist in other QA areas, cross-train across the department as needed, and complete other APR tasks assigned by the Supervisor or Quality Senior Management.