Director, Quality Control & Compliance Leader

Minaris Advanced Therapies; Allendale (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Minaris Advanced Therapies in Allendale, NJ, seeks a Senior Director of Quality to oversee Quality Control for analytical and microbiological labs at Clinical and Commercial sites. You will manage resources, data integrity programs, and external laboratory relationships to ensure client requirements are met.

Responsibilities include leading audits, regulatory interactions, method validation, and continuous improvement in a fast-paced environment.

Qualifications

• Bachelor of Science in biological sciences or related field; advanced degree preferred.
• Minimum 15 years relevant experience with 5–10 years in management overseeing a lab environment (clinical or commercial).
• Knowledge of FDA/EMEA regulations and root-cause analysis.
• Experience in cGMP documentation (investigations, validation/qualification, SOPs).
• Experience leading teams and participating in health authority inspections and client audits.

Responsibilities

• Ensure production support and cGMP compliance.
• Manage laboratory resources (people and budgets) and CapEx.
• Oversee QC standards, instruments, methods, and electronic systems (LIMS).
• Ensure regulatory-compliant analytical, micro, and environmental monitoring programs.
• Lead method validation and tech transfer activities.
• Ensure instrumentation is validated and QC readiness is maintained.
• Support timely product release across Planning, Operations, and Supply Chain.
• Lead laboratory investigations (OOS/OOT) and drive root-cause analysis.
• Provide leadership and development for laboratory personnel.

Skills

Strategic thinking

Cross-functional collaboration

Analytical and problem-solving

Written and oral communication

Meeting management

Task prioritization

Adaptability

Business acumen

Autonomy

Education

Bachelor of Science in biological sciences

Advanced degree preferred

Tools

LIMS

Job description

Minaris Advanced Therapies in Allendale, NJ, seeks a Senior Director of Quality to oversee Quality Control for analytical and microbiological labs at Clinical and Commercial sites. You will manage resources, data integrity programs, and external laboratory relationships to ensure client requirements are met.

Responsibilities include leading audits, regulatory interactions, method validation, and continuous improvement in a fast-paced environment.