Quality Assurance Manager | Bentley Labs

THG•Edison, NJ

9d•Onsite

About The Position

The Quality Assurance Manager leads Quality Assurance activities across manufacturing, filling, packaging, and assembly operations at Bentley Laboratories. The role ensures product quality, regulatory compliance, GMP adherence, audit readiness, and continuous improvement through effective management of quality systems, investigations, CAPAs, documentation, and personnel. It includes hands-on oversight of raw material, bulk product, and finished goods testing; in-process inspections; line clearances; investigations; and continuous improvement initiatives. The manager is a visible quality leader who promotes accountability, data integrity, compliance, and cross-functional collaboration.

Requirements

Bachelor's degree in Chemistry, Biology, Quality Management, Engineering, Manufacturing, or a related field, or equivalent experience.
At least 7 years of Quality Assurance experience within a regulated manufacturing environment.
At least 3 years of people management experience.
Experience managing investigations, CAPAs, change controls, audits, and quality systems.
Strong knowledge of FDA regulations, cGMP requirements, and quality management systems.
Experience leading teams and driving continuous improvement initiatives.
Proficiency in Microsoft Office, electronic QMS platforms, ERP systems, and reporting tools.
Strong analytical, problem-solving, documentation, and communication skills.

Nice To Haves

Experience within OTC pharmaceuticals, cosmetics, personal care, or contract manufacturing.
Experience supporting FDA inspections and customer audits.
Knowledge of ISO 22716, validation, qualification, and risk management processes.
Experience implementing or improving quality management systems.

Responsibilities

Provide quality oversight across manufacturing and packaging operations.
Review quality data, investigate nonconformances, and support product disposition decisions.
Ensure compliance with approved specifications, procedures, and manufacturing documentation, and identify, escalate, and support resolution of quality and compliance issues.
Maintain compliance with FDA regulations, cGMP requirements, ISO 22716, and internal quality standards.
Conduct GMP audits, quality inspections, and compliance assessments, and ensure audit and inspection readiness across quality systems.
Promote best practices in documentation, traceability, contamination control, and product quality.
Lead deviations, nonconformance investigations, root cause analyses, and product quality reviews.
Manage CAPAs to ensure timely implementation and effectiveness; support change controls, validations, and process improvement initiatives; and escalate recurring compliance or quality risks.
Ensure records are accurate, complete, and compliant with ALCOA+ principles.
Oversee quality documentation, electronic quality systems, and document control processes, and address data integrity and documentation concerns.
Drive continuous improvement in quality reporting and record management.
Lead, coach, and develop QA personnel; set performance expectations; oversee training and competency programs; and support succession planning and employee development.
Foster a culture of accountability, collaboration, and continuous improvement.
Communicate quality performance, investigations, audit findings, and compliance risks; provide objective, risk-based recommendations; and ensure timely escalation of significant quality concerns.
Develop and monitor KPIs for CAPA effectiveness, investigation closure timelines, audit performance, training compliance, documentation accuracy, quality system effectiveness, customer complaints, and supplier quality.
Analyze trends, implement improvement initiatives, and report quality metrics and compliance performance to leadership.
Partner with Manufacturing, Quality Control, Engineering, Warehouse, Planning, and R&D teams.
Support customer audits, regulatory inspections, and remediation activities, and keep quality records, investigations, and training documentation inspection-ready.
Provide quality guidance and support across the business.
Ensure effective delivery of daily Quality Assurance activities, balance operational priorities with strategic projects and continuous improvement, and identify resource needs and recommend solutions.