Quality Manager – Regulated Health Products & GMP

Carl Zeiss Vision, Inc.; Princeton (NJ); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay from your first‑

Job summary

ZEISS in New Jersey seeks a hands-on Quality Manager to support GMP quality for OTC sterile eye drops, dietary supplements, cosmetics, and related products. You will build inspection-ready systems, partner with 3PLs, and ensure compliant movement through warehousing and logistics networks.

The role requires cross-functional collaboration with Regulatory Affairs, Supplier Quality, Operations, and external partners to translate regulatory expectations into procedures and training.

Qualifications

• 5+ years of experience in Quality Assurance, Quality Systems, Supplier Quality, Regulatory Affairs, or Compliance within an FDA-regulated industry.
• Direct experience in OTC drugs, pharmaceuticals, sterile products, medical devices, dietary supplements, cosmetics, or regulated consumer health products.
• Strong QA competencies: deviations, CAPA, change control, document control, complaints, supplier quality, training, and audit readiness.
• Supply chain/logistics exposure with 3PLs, distributors, warehouses, or outsourced manufacturers.
• Ability to review technical quality documentation and drive required follow-up.
• Excellent written and verbal communication to translate regulatory/quality expectations into procedures.

Responsibilities

• Provide direct quality oversight of local warehousing, 3PL partners, distribution processes, and CRT storage programs.
• Maintain practical QMS for assigned regulated products and distribution activities.
• Review documentation: CoA, CoC, deviations, CAPA, and supplier quality records.
• Support product disposition, supplier quality audits, and CAPA tracking.
• Coordinate adverse event escalations with Regulatory Affairs and external partners.
• Lead readiness for FDA, customer, and internal audits; drive continuous improvement.

Skills

Quality Assurance

Quality Systems

Regulatory Affairs

Cross-functional collaboration

Quality leadership

Education

Bachelor's degree preferred

Equivalent industry experience considered

Tools

QMS familiarity

Documentation control

Job description

ZEISS in New Jersey seeks a hands-on Quality Manager to support GMP quality for OTC sterile eye drops, dietary supplements, cosmetics, and related products. You will build inspection-ready systems, partner with 3PLs, and ensure compliant movement through warehousing and logistics networks.

The role requires cross-functional collaboration with Regulatory Affairs, Supplier Quality, Operations, and external partners to translate regulatory expectations into procedures and training.