Lead and coordinate quality recordsforV2V Operations, includingchange controls, deviations, and CAPAs, from initiation through closure, ensuring timely progression, complete documentation, and alignment with internal quality expectations.

Partner with SMEs and process ownersto develop robust and compliant record content, includingproblem statements, impact assessments, root cause analyses, corrective and preventive actions, implementation plans, and effectiveness considerations.

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

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

Facilitate and support quality risk assessmentsrelated toV2V activitiesandCOI/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 controlsso that risk-based decisions are consistently reflected across documentation and operational practice.

Support the lifecycle management of quality procedures, includingSOPs, 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 trendsfor theV2V Operationsteam, including measures such as record volume, aging, overdue actions, closure timeliness, recurrence, CAPA implementation, and procedural compliance indicators.

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

Support continuous improvementby 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 risksthrough the appropriate management and Quality channels, applying sound judgment on matters requiring higher-level attention.

Support inspection and audit readinessthrough accurate documentation, effective tracking, organized record management, and readiness of quality system evidence relevant toV2V Operations.

Collaborate effectively across functionswithV2V Operations SMEs,Quality Assurance, technical teams, and other stakeholders to ensure timely and compliant execution of quality system activities.

Bachelors degreein ascientific, technical, engineering, quality, or related discipline, or equivalent relevant experience.

5+ years' experience in aGxP-regulated environmentwith solid knowledge ofquality systemsand documentation requirements.

Demonstrated experience withdeviations, CAPAs, change controls, and controlled document management.

Experience supporting or facilitatingquality risk assessments.

Experience drafting, reviewing, or maintainingSOPsor similar controlled procedures.

Experience compiling, reviewing, or interpretingquality 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.

Experience incell therapy, supply chain, manufacturing

Familiarity withCOI/COC-related processesand associated quality expectations.

Experience working in across-functional or matrixed environment.

Experience supportingaudits, inspections, or internal quality reviews.

Working knowledge ofroot cause analysis tools, risk management methodologies, and continuous improvement practices.

Strong understanding ofquality management systemsandgood documentation practices.

Ability to applyrisk-based thinkingto 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.