GMP Quality Operations Director - Biotech & Cell Therapy

Fairway Consulting Group; North Carolina; On-site; USD 180,000 - 240,000; Full time

Job summary

Fairway Consulting Group seeks a Senior Director of Quality Operations for a clinical-stage biotechnology client. You will lead QA functions supporting product and material release and validation activities, ensuring GMP quality oversight across manufacturing and analytical operations.

You will manage clinical batch disposition, raw material release, and QA oversight of equipment validation, risk assessments, CAPA, and regulatory compliance across U.S. and EU environments.

Qualifications

• 10+ years in biologics, cell therapy, gene therapy, or complex biopharmaceutical manufacturing environments.
• Experience in GMP-regulated environments including batch documentation review, deviations, investigations, change control, CAPA, and quality systems.
• Familiarity with validation/qualification activities involving GMP equipment, facilities, utilities, and related systems.

Responsibilities

• Lead QA functions supporting product release, material release, and validation activities.
• Oversee clinical batch disposition through review of batch documentation, deviations, investigations, and quality records for release suitability.
• Manage release and disposition of GMP raw materials used in manufacturing.
• Provide QA oversight of validation/qualification activities for GMP equipment, facilities, systems, and upgrades.
• Lead quality risk assessments and mitigation strategies to support compliant product development and manufacturing.
• Oversee non-conformance, deviation, and CAPA processes including investigations and root cause analysis.
• Ensure compliance with U.S. and EU cGMP requirements and industry standards.
• Provide leadership, mentoring, and development to Quality personnel across Manufacturing and related functions.
• Drive continuous improvement initiatives to strengthen GMP quality systems and operational performance.
• Identify and resolve product quality issues with cross-functional collaboration.

Skills

Leadership

Quality Assurance

GMP

Regulatory CMC

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in a scientific discipline

Job description

Fairway Consulting Group seeks a Senior Director of Quality Operations for a clinical-stage biotechnology client. You will lead QA functions supporting product and material release and validation activities, ensuring GMP quality oversight across manufacturing and analytical operations.

You will manage clinical batch disposition, raw material release, and QA oversight of equipment validation, risk assessments, CAPA, and regulatory compliance across U.S. and EU environments.