Senior Quality Leader, Regulatory & Microbiology

DC Enterprises (iLABS Inc. and Affiliated Companies:); Mahwah (NJ); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Paid time off

Monthly celebrations

Daily meals

Job summary

DC Enterprises (iLABS Inc. and Affiliated Companies:) is seeking a Sr. Quality Manager to lead QA, QC and Microbiology for cosmetics, OTC drugs, dietary supplements, ensuring product quality and regulatory compliance under FDA/cGMP standards.

The role entails directing audits, CAPAs, and change controls, supporting inspections, and driving continuous improvement across manufacturing and testing processes with a strong focus on consumer safety.

Qualifications

• 8+ years of progressive Quality Management experience in a regulated manufacturing environment.
• Strong knowledge of 21 CFR Parts 210/211, 111, 820, ISO 13485 and Cosmetic GMPs.
• Experience with FDA inspections, ISO audits, third-party audits, CAPA, change control, validation, supplier quality.

Responsibilities

• Lead QA, QC and Microbiology functions ensuring compliant product manufacture, testing, release and distribution.
• Oversee deviations, complaints, CAPAs, recalls and investigations with root-cause analysis.
• Manage supplier qualification, quality agreements, and third-party laboratories.
• Build and develop a qualified quality team and foster a culture of continuous improvement.

Skills

Quality leadership

Audits & inspections

Regulatory judgment

Communication

eQMS / LIMS / ERP

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree preferred

Tools

eQMS

LIMS

ERP systems

Job description

DC Enterprises (iLABS Inc. and Affiliated Companies:) is seeking a Sr. Quality Manager to lead QA, QC and Microbiology for cosmetics, OTC drugs, dietary supplements, ensuring product quality and regulatory compliance under FDA/cGMP standards.

The role entails directing audits, CAPAs, and change controls, supporting inspections, and driving continuous improvement across manufacturing and testing processes with a strong focus on consumer safety.