QA Leader – GMP Compliance & Quality Transformation

Apex Systems; Lebanon (NJ); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

ESPP

401K program with company match

HSA (Health Savings Account)

Employee Assistance Program (EAP)

Certification discounts

Job summary

Everforth Apex in Lebanon, New Jersey, is seeking a QA Manager to lead a growing quality team onsite. You will own the QMS, mentor staff, and support frequent client audits and regulatory inspections with a strong focus on continuous improvement.

The role requires hands-on GMP/QMS leadership, collaboration with Operations, and a proactive approach to CAPAs, deviations and risk assessments to ensure data integrity and regulatory readiness.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 7+ years of QA experience in pharma/biotech/contract labs.
• 3+ years of leadership experience and GMP/FDA QA leadership.
• Strong knowledge of FDA regulations, cGMP, ICH and lab compliance.
• Experience hosting client audits and regulatory inspections.

Responsibilities

• Manage and maintain the Quality Management System (QMS) with KPI reporting.
• Provide QA oversight of analytical operations and GMP testing activities.
• Lead and develop QA team to foster quality and continuous improvement.
• Serve as primary QA representative during audits and inspections.
• Oversee deviations, CAPAs, change controls, risk assessments, investigations.
• Partner with clients to address quality inquiries and support projects.
• Establish quality metrics and drive operational compliance.
• Ensure data integrity per ALCOA+ principles.

Skills

QA Leadership

GMP Compliance

FDA Regulations

Audit Readiness

Mentoring

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences

Tools

eQMS

Job description

Everforth Apex in Lebanon, New Jersey, is seeking a QA Manager to lead a growing quality team onsite. You will own the QMS, mentor staff, and support frequent client audits and regulatory inspections with a strong focus on continuous improvement.

The role requires hands-on GMP/QMS leadership, collaboration with Operations, and a proactive approach to CAPAs, deviations and risk assessments to ensure data integrity and regulatory readiness.