Senior Director Quality Operations

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

Our client is a clinical-stage biotechnology company advancing innovative cell therapies for serious diseases. They have asked us to assist them in their search for a Senior Director, Quality Operations.

Responsibilities:

• Lead Quality Assurance functions supporting product release, material release, and validation activities, ensuring effective oversight of GMP quality operations.
• Oversee clinical batch disposition through review of batch documentation, deviations, investigations, and supporting quality records to determine product release suitability.
• Manage the release and disposition of GMP raw materials used in manufacturing.
• Provide Quality Assurance oversight of validation and qualification activities for GMP equipment, facilities, systems, and related upgrades.
• Lead quality risk assessments and implement appropriate mitigation strategies to support compliant product development and manufacturing.
• Oversee non-conformance, deviation, and CAPA processes, including investigation review, root cause analysis, and documentation.
• Ensure compliance with U.S. and EU cGMP requirements and applicable industry standards.
• Provide leadership, mentoring, and development to Quality personnel while promoting strong quality practices across Manufacturing and related functions.
• Drive continuous improvement initiatives to strengthen GMP quality systems and operational performance.
• Identify and resolve product quality issues while maintaining effective cross-functional collaboration.
• Evaluate manufacturing programs and operations for GMP readiness through structured risk and compliance assessments.
• Monitor quality metrics and operational KPIs and implement corrective actions to address emerging trends or compliance gaps.
• Lead cross-functional quality initiatives and complex projects aligned with organizational objectives and development timelines.
• Strengthen GMP compliance through effective change control and adherence to established procedures and quality standards.
• Support consistent clinical supply through coordinated quality oversight across Manufacturing, Analytical, Regulatory, Supply Chain, and other operational functions.
• Contribute to the continued development of quality systems and processes required to support progression from late-stage clinical development toward commercialization.

We seek candidates with the following qualifications:

• Bachelor’s degree in scientific discipline, engineering, healthcare field, or related area.
• Minimum of 10 years of relevant experience within biologics, cell therapy, gene therapy, or other complex biopharmaceutical manufacturing environments.
• Experience in biologics or cell therapy manufacturing and/or analytical testing is preferred.
• Broad experience within Quality Assurance, with exposure to related functions such as Manufacturing, Process Development, Analytical Development, Supply Chain, Materials Management, or Regulatory CMC.
• Demonstrated experience working in GMP-regulated environments, including batch documentation review, deviations, investigations, change control, CAPA, and quality systems.
• Familiarity with validation and qualification activities involving GMP equipment, facilities, utilities, and related systems.
• Experience supporting or participating in quality audits and regulatory inspections. Experience with both U.S. and European regulatory authorities is preferred.
• Working knowledge of clinical development, R&D, and clinical supply operations within pharmaceutical or biotechnology organizations.
• Understanding of quality requirements associated with late-stage clinical manufacturing and progression toward commercial readiness.
• Strong analytical and problem-solving skills with the ability to assess and resolve complex technical and quality issues.
• Demonstrated ability to lead cross-functional initiatives and operate effectively in a dynamic biotechnology environment.
• Strong communication, collaboration, and leadership skills.