Director of Quality Control & Lab Excellence

Minaris; Allendale (NJ); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Dental insurance

401(k)

Paid time off

Job summary

Minaris Advanced Therapies seeks a Senior Director of Quality responsible for oversight of Analytical and Microbiological QC at Clinical and Commercial sites in Allendale, NJ. You will manage laboratories, budgets, and data integrity programs while ensuring regulatory compliance.

The role leads QC investigations, participates in audits, and partners across departments to support timely product release and continuous improvement.

Qualifications

• Bachelor of Science in biological sciences or related field; advanced degree preferred.
• Minimum of 15 years of relevant experience, including 5–10 years in a management role overseeing a laboratory environment.
• Experience with environmental monitoring and aseptic processing is preferred.
• Knowledge of FDA and EMEA regulations and root-cause analysis.
• Experience in authoring, reviewing, and/or approving cGMP documents and SOPs.
• Experience participating in health authority inspections and client audits.

Responsibilities

• Lead Quality Control for analytical, microbiological labs at Clinical and Commercial sites.
• Oversee budgets, resources, and CapEx within scope.
• Ensure QC cGMP readiness and compliance across labs and processes.
• Coordinate with Planning, Operations, and Supply Chain to ensure timely product release.
• Drive data integrity, investigations (OOS/OOT), and continuous improvement.

Education

Bachelor of Science in biological sciences or related field

Advanced degree preferred

Job description

Minaris Advanced Therapies seeks a Senior Director of Quality responsible for oversight of Analytical and Microbiological QC at Clinical and Commercial sites in Allendale, NJ. You will manage laboratories, budgets, and data integrity programs while ensuring regulatory compliance.

The role leads QC investigations, participates in audits, and partners across departments to support timely product release and continuous improvement.