Thehutgroup
Quality Assurance Manager | Bentley Labs
US, New Jersey. Posted 14 days ago
The role
The Quality Assurance Manager leads quality activities across manufacturing, filling, packaging, and assembly operations. This role ensures product quality, regulatory compliance, and GMP adherence through management of quality systems, investigations, and personnel.
What you will do
- 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.
- Maintain compliance with FDA regulations, cGMP requirements, ISO 22716, and internal quality standards.
- Conduct GMP audits, quality inspections, and compliance assessments.
- Lead deviations, nonconformance investigations, root cause analyses, and product quality reviews.
- Manage CAPAs to ensure timely implementation and effectiveness.
- Lead, coach, and develop QA personnel.
- Develop and monitor KPIs related to CAPA effectiveness, investigation timelines, and audit performance.
- Partner with Manufacturing, Quality Control, Engineering, Warehouse, Planning, and R&D teams.
Required qualifications
- 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
- Work in office, laboratory, and manufacturing environments
- Frequent sitting, standing, walking, and computer use
- Occasional lifting of up to 25 lbs
- Ability to wear PPE and work safely around manufacturing processes
Nice to have
- 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
About the company
THG is a global ecommerce group in beauty and sports nutrition. Bentley Laboratories is a premier beauty contract manufacturer based in Edison, NJ.