Senior Director Quality Operations

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.