Quality Assurance Manager | Bentley Labs
About The Position
The Quality Assurance Manager leads Quality Assurance activities across manufacturing, filling, packaging, and assembly operations at Bentley Labs. The role ensures product quality, regulatory compliance, GMP adherence, audit readiness, and continuous improvement through 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; CAPAs; and continuous improvement initiatives. The manager serves as a visible quality leader who promotes accountability, data integrity, compliance, and cross-functional collaboration. The position oversees quality operations and systems, supports product disposition decisions, maintains compliance with applicable FDA and cGMP requirements, ISO 22716, and internal standards, and leads investigations, root cause analyses, change controls, and CAPA management. It also ensures accurate and inspection-ready records, develops QA personnel, communicates performance and risks to stakeholders, monitors quality KPIs, and partners with cross-functional teams on audits, inspections, remediation, and operational priorities. The role is based in Edison, New Jersey, at 50 Clearview Road and 111 Fieldcrest Avenue. Compensation is $95,000–$105,000 annually, based on experience, skills, and qualifications.
Requirements
- Bachelor's degree in Chemistry, Biology, Quality Management, Engineering, Manufacturing, or a related field, or equivalent experience.
- 7+ years of Quality Assurance experience within a regulated manufacturing environment.
- 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.
- 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.
- 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; 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.
- Identify and address data integrity and documentation concerns; improve quality reporting and record management.
- Lead, coach, and develop QA personnel; set performance expectations and oversee training and competency programs.
- Support succession planning and employee development, and foster accountability, collaboration, and continuous improvement.
- Communicate quality performance, investigations, audit findings, and compliance risks; provide objective, risk-based recommendations and timely escalation.
- Develop and monitor KPIs covering 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; keep quality records, investigations, and training documentation inspection-ready.
- Provide quality guidance and support across the business.
- Ensure effective delivery of daily QA activities, balance operational priorities with strategic projects, and identify resource needs and recommend solutions.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
