Senior Specialist, Cell Therapy Vein-to-Vein Operations

Key Responsibilities 

• Lead and coordinate quality records for V2V Operations, including change controls, deviations, and CAPAs, from initiation through closure, ensuring timely progression, complete documentation, and alignment with internal quality expectations.

• Partner with SMEs and process owners to develop robust and compliant record content, including problem statements, impact assessments, root cause analyses, corrective and preventive actions, implementation plans, and effectiveness considerations. 

• Review and challenge documentation quality to ensure records are clear, scientifically sound, appropriately justified, traceable, and consistent across related records and supporting documentation. 

• Drive follow-up and maintain visibility of record status, action progress, aging, and closure timelines, escalating concerns where compliance, quality, or delivery is at risk. 

• Facilitate and support quality risk assessments related to V2V activities and COI/COC-related processes, ensuring risks, controls, residual risks, and mitigation plans are clearly documented and linked to appropriate actions. 

• Maintain alignment between risk assessments, quality records, and procedural controls so that risk-based decisions are consistently reflected across documentation and operational practice. 

• Support the lifecycle management of quality procedures, including SOPs, work instructions, templates, and other controlled documents, through drafting, revision, review coordination, implementation support, and periodic maintenance. 

• Help ensure procedures remain current and effective, aligned with operational practice, quality requirements, lessons learned, and outcomes from deviations, CAPAs, audits, inspections, and trend reviews. 

• Compile, analyze, and communicate quality metrics and trends for the V2V Operations team, including measures such as record volume, aging, overdue actions, closure timeliness, recurrence, CAPA implementation, and procedural compliance indicators. 

• Translate quality data into actionable insights by identifying recurring themes, emerging risks, and improvement opportunities, and by supporting governance discussions and management review. 

• Support continuous improvement by using learnings from quality records, metrics, audits, inspections, and stakeholder feedback to strengthen processes, documentation quality, and preventive controls. 

• Escalate significant quality, compliance, timing, or resource risks through the appropriate management and Quality channels, applying sound judgment on matters requiring higher-level attention. 

• Support inspection and audit readiness through accurate documentation, effective tracking, organized record management, and readiness of quality system evidence relevant to V2V Operations. 

• Collaborate effectively across functions with V2V Operations SMEs, Quality Assurance, technical teams, and other stakeholders to ensure timely and compliant execution of quality system activities. 

Required Qualifications and Experience 

• Bachelor’s degree in a scientific, technical, engineering, quality, or related discipline, or equivalent relevant experience. 

• 5+ years' experience in a GxP-regulated environment with solid knowledge of quality systems and documentation requirements. 

• Demonstrated experience with deviations, CAPAs, change controls, and controlled document management. 

• Experience supporting or facilitating quality risk assessments. 

• Experience drafting, reviewing, or maintaining SOPs or similar controlled procedures. 

• Experience compiling, reviewing, or interpreting quality metrics and trend data. 

• Strong written and verbal communication skills, with the ability to work effectively across technical and non-technical stakeholder groups. 

• Strong organizational skills and the ability to manage multiple priorities and deadlines with limited supervision. 

Preferred Experience 

• Experience in cell therapy, supply chain, manufacturing

• Familiarity with COI/COC-related processes and associated quality expectations. 

• Experience working in a cross-functional or matrixed environment. 

• Experience supporting audits, inspections, or internal quality reviews. 

• Working knowledge of root cause analysis tools, risk management methodologies, and continuous improvement practices. 

Key Skills 

• Strong understanding of quality management systems and good documentation practices. 

• Ability to apply risk-based thinking to operational quality activities.

• Strong analytical capability to identify themes, trends, and emerging risks from quality data. 

• Strong procedural writing and document review skills. 

• Ability to influence and coordinate across functions without direct authority. 

• Sound judgment in identifying issues, driving follow-up, and escalating where appropriate. 

• Ability to balance detail orientation with timely delivery in a fast-paced environment.